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Clinical Trial Results:
Multi-centre, open-label clinical trial to evaluate the efficacy and safety of Rhodiola rosea extract (Rosalin) in Subjects with Burnout Symptoms

Summary
EudraCT number	2010-022686-10
Trial protocol	AT
Global end of trial date	24 Feb 2014

Results information
Results version number	v1(current)
This version publication date	01 Mar 2016
First version publication date	02 Aug 2015
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

578001.01.012

ISRCTN number

ISRCTN31235821

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

Dr. Willmar Schwabe GmbH & Co. KG

Sponsor organisation address

Willmar Schwabe Str. 4, Karlsruhe, Germany, 76227

Public contact

Clinical Research Department, Dr. W. Schwabe GmbH & Co. KG, +49 (0)714005573,

Scientific contact

Clinical Research Department, Dr. W. Schwabe GmbH & Co. KG, +49 (0)714005573,

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

24 Feb 2014

Is this the analysis of the primary completion data?

Yes

Primary completion date

24 Feb 2014

Global end of trial reached?

Yes

Global end of trial date

24 Feb 2014

Was the trial ended prematurely?

Main objective of the trial

The objective of the trial is to describe the therapeutic effects, safety and tolerability of Rhodiola rosea extract (Rosalin) in subjects with Burnout symptoms

Protection of trial subjects

Possibility to withdraw consent by subjects. Monitoring of adverse events and laboratory parameters.

Background therapy

Evidence for comparator

Actual start date of recruitment

21 Jul 2011

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Austria: 131

Worldwide total number of subjects

131

EEA total number of subjects

131

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

131

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

Subjects were recruited in four investigational sites.

Number of subjects started

131

Number of subjects completed

118

Reason: Number of subjects

Physician decision: 12

Reason: Number of subjects

Consent withdrawn by subject: 1

Period 1 title

Treatment period (overall period)

Is this the baseline period?

Yes

Allocation method

Not applicable

Blinding used

Not blinded

Are arms mutually exclusive

Baseline

Arm description

Baseline before starting treatment with Rhodiola rosea extract (Rosalin)

Arm type

Baseline

Investigational medicinal product name

No investigational medicinal product assigned in this arm

Rhodiola rosea extract (Rosalin)

Arm description

Investigational medical product containing (Rosalin), two film-coated tablets of 200 mg Rhodiola rosea extract

Arm type

Experimental

Investigational medicinal product name

Rhodiola rosea extract (Rosalin)

Investigational medicinal product code

Other name

Pharmaceutical forms

Film-coated tablet

Routes of administration

Oral use

Dosage and administration details

1 film-coated tablet 2 times per day for 12 consecutive weeks

Number of subjects in period 1	Baseline	Rhodiola rosea extract (Rosalin)
Started	118	118
Completed	118	100
Not completed	0	18
private reasons	-	1
Physician decision	-	1
Adverse event, non-fatal	-	4
Lost to follow-up	-	8
Lack of efficacy	-	4

Baseline characteristics

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Reporting group title

Treatment period (overall period)

Reporting group description

In total, 118 subjects received the investigational treatment.

Notes
[1] - The number of subjects reported to be in the baseline period is not equal to the worldwide number of subjects enrolled in the trial. It is expected that these numbers will be the same.
Justification: In total, 13 of the 131 subjects screened for inclusion into the study were not included into the baseline period.

Reporting group values	Treatment period (overall period)	Total
Number of subjects	118	118
Age categorical
Units: Subjects
In utero	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0
Newborns (0-27 days)	0	0
Infants and toddlers (28 days-23 months)	0	0
Children (2-11 years)	0	0
Adolescents (12-17 years)	0	0
Adults (18-64 years)	118	118
From 65-84 years	0	0
85 years and over	0	0
Age continuous
Units: years
arithmetic mean (standard deviation)	43.5 ± 8.1	-
Gender categorical
Units: Subjects
Female	69	69
Male	49	49

Subject analysis set title

Full analysis set

Subject analysis set type

Full analysis

Subject analysis set description

The full analysis set consists of all subjects having received investigational product at least once and having at least one post baseline measurement of one of the rating scales

Subject analysis sets values	Full analysis set
Number of subjects	117
Age categorical
Units: Subjects
In utero	0
Preterm newborn infants (gestational age < 37 wks)	0
Newborns (0-27 days)	0
Infants and toddlers (28 days-23 months)	0
Children (2-11 years)	0
Adolescents (12-17 years)	0
Adults (18-64 years)	117
From 65-84 years	0
85 years and over	0
Age continuous
Units: years
arithmetic mean (standard deviation)	43.7 ± 8
Gender categorical
Units: Subjects
Female	68
Male	49

End points

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Reporting group title

Baseline

Reporting group description

Baseline before starting treatment with Rhodiola rosea extract (Rosalin)

Reporting group title

Rhodiola rosea extract (Rosalin)

Reporting group description

Investigational medical product containing (Rosalin), two film-coated tablets of 200 mg Rhodiola rosea extract

Subject analysis set title

Full analysis set

Subject analysis set type

Full analysis

Subject analysis set description

The full analysis set consists of all subjects having received investigational product at least once and having at least one post baseline measurement of one of the rating scales

Primary: Change in subscale depersonalisation of the Maslach-Burnout-Inventory (MBI) between baseline and end of treatment

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End point title

Change in subscale depersonalisation of the Maslach-Burnout-Inventory (MBI) between baseline and end of treatment

End point description

The 25-question Maslach Burnout Inventory consists of the four subscales emotional exhaustion (9 items), depersonalisation (5 items), involvement (3 items) and personal accomplishment (8 items). Each item is rated by the subject on the two dimension frequency using a scale from 0 = never to 6 = every day. Subscale depersonalisation: Items 5, 10, 11, 15, and 22. The score is calculated by the sum of all items responded to divided by the number of items responded to. Higher scores indicate a higher burnout level. Note: Due to the character of the study, no differentiation in primary and secondary outcome variables was intended. Because at least one primary end point is required to enter study results into the database, all outcome variables are presented using the end point type primary. Baseline is defined as the last measurement before first intake of study drug.

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	117
Units: points
arithmetic mean (standard deviation)	1.83 ± 1.21	1.4 ± 1.28

Non-parametric analysis

Statistical analysis description

Baseline and end of treatment values available for 117 subjects; LOCF; two-sided, confidence interval for mean difference is based on t-distribution. The number of subjects included in analysis was summarized to 234 (Baseline 117, End of treatment 117) because of requirements of the Eudra-CT data base.

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

234

Analysis specification

Pre-specified

Analysis type

other ^[1]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-0.43

Confidence interval

level

95%

sides

2-sided

lower limit

-0.7

upper limit

-0.2

Variability estimate

Standard deviation

Dispersion value

1.22

Notes
[1] - Within-subject change between baseline and end of treatment

Primary: Change in subscale emotional exhaustion of the Maslach-Burnout-Inventory (MBI) between baseline and end of treatment

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End point title

Change in subscale emotional exhaustion of the Maslach-Burnout-Inventory (MBI) between baseline and end of treatment

End point description

The 25-question Maslach Burnout Inventory consists of the four subscales emotional exhaustion (9 items), depersonalisation (5 items), involvement (3 items) and personal accomplishment (8 items). Each item is rated by the subject on the two dimension frequency using a scale from 0 = never to 6 = every day. Subscale emotional exhaustion: Items 1, 2, 3, 6, 8, 13, 14, 16, and 20. The score is calculated by the sum of all items responded to divided by the number of items responded to. Higher scores indicate a higher burnout level. Note: Due to the character of the study, no differentiation in primary and secondary outcome variables was intended. Because at least one primary end point is required to enter study results into the database, all outcome variables are presented using the end point type primary. Baseline is defined as the last measurement before first intake of study drug

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	117
Units: points
arithmetic mean (standard deviation)	2.57 ± 0.3	2.29 ± 1.04

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

234

Analysis specification

Pre-specified

Analysis type

other ^[2]

P-value

= 0.0003

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-0.28

Confidence interval

level

95%

sides

2-sided

lower limit

-0.5

upper limit

-0.1

Variability estimate

Standard deviation

Dispersion value

1.02

Notes
[2] - Within-subject change between baseline and end of treatment

Primary: Change in subscale involvement of the Maslach-Burnout-Inventory (MBI) between baseline and end of treatment

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End point title

Change in subscale involvement of the Maslach-Burnout-Inventory (MBI) between baseline and end of treatment

End point description

The 25-question Maslach Burnout Inventory consists of the four subscales emotional exhaustion (9 items), depersonalisation (5 items), involvement (3 items) and personal accomplishment (8 items). Each item is rated by the subject on the two dimension frequency using a scale from 0 = never to 6 = every day. Subscale involvement: Items 23, 24, and 25. The score is calculated by the sum of all items responded to divided by the number of items responded to. Higher scores indicate a higher burnout level. Note: Due to the character of the study, no differentiation in primary and secondary outcome variables was intended. Because at least one primary end point is required to enter study results into the database, all outcome variables are presented using the end point type primary. Baseline is defined as the last measurement before first intake of study drug

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	117
Units: points
arithmetic mean (standard deviation)	2.13 ± 1.31	2.03 ± 1.31

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

234

Analysis specification

Pre-specified

Analysis type

other ^[3]

P-value

= 0.1714

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-0.11

Confidence interval

level

95%

sides

2-sided

lower limit

-0.3

upper limit

0.1

Variability estimate

Standard deviation

Dispersion value

1.32

Notes
[3] - Within-subject change between baseline and end of treatment

Primary: Change in subscale personal accomplishment of the Maslach-Burnout-Inventory (MBI) between baseline and end of treatment

Top of page

End point title

Change in subscale personal accomplishment of the Maslach-Burnout-Inventory (MBI) between baseline and end of treatment

End point description

The 25-question Maslach Burnout Inventory consists of the four subscales emotional exhaustion (9 items), depersonalisation (5 items), involvement (3 items) and personal accomplishment (8 items). Each item is rated by the subject on the two dimension frequency using a scale from 0 = never to 6 = every day. Subscale personal accomplishment: Items 4, 7, 9, 12, 17, 18, 19, and 21. The score is calculated by the sum of all items responded to divided by the number of items responded to. Lower scores indicate a higher burnout level. Note: Due to the character of the study, no differentiation in primary and secondary outcome variables was intended. Because at least one primary end point is required to enter study results into the database, all outcome variables are presented using the end point type primary. Baseline is defined as the last measurement before first intake of study drug.

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	117
Units: points
arithmetic mean (standard deviation)	4.3 ± 0.41	4.32 ± 0.94

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

234

Analysis specification

Pre-specified

Analysis type

other ^[4]

P-value

= 0.4643

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

0.03

Confidence interval

level

95%

sides

2-sided

lower limit

-0.1

upper limit

0.2

Variability estimate

Standard deviation

Dispersion value

0.81

Notes
[4] - Within-subject change between baseline and end of treatment

Primary: Change in global score intensity value of the Burnout Screening Scale (BOSS I) between baseline and end of treatment

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End point title

Change in global score intensity value of the Burnout Screening Scale (BOSS I) between baseline and end of treatment

End point description

The Burnout-Screening Scale (BOSS I) is a self-rating scale. All items are evaluated on a scale from 0 (‘not applicable’) to 5 (‘highly applicable’). For the global score (all items) three different scores were calculated: an intensity value as an average measure considering only applicable items, a relative width (originally “Breitenwert”) and a total average value as a measure for the average stress within the subscale. Note: Due to the character of the study, no differentiation in primary and secondary outcome variables was intended. Because at least one primary end point is required to enter study results into the database, all outcome variables are presented using the end point type primary. Baseline is defined as the last measurement before first intake of study drug.

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	116
Units: points
arithmetic mean (standard deviation)	2.64 ± 0.71	1.94 ± 0.69

Non-parametric analysis

Statistical analysis description

Baseline values available for 117 subjects, end of treatment values available for 116 subjects; LOCF; two-sided, confidence interval for mean difference is based on t-distribution evaluated for 116 subjects. The number of subjects included in analysis was summarized to 233 (Baseline 117, End of treatment 116) because of requirements of the Eudra-CT data base.

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

233

Analysis specification

Pre-specified

Analysis type

other ^[5]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-0.71

Confidence interval

level

95%

sides

2-sided

lower limit

-0.9

upper limit

-0.6

Variability estimate

Standard deviation

Dispersion value

0.76

Notes
[5] - Within-subject change between baseline and end of treatment

Primary: Change in global score relative width value of the Burnout Screening Scale (BOSS I) between baseline and end of treatment

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End point title

Change in global score relative width value of the Burnout Screening Scale (BOSS I) between baseline and end of treatment

End point description

The Burnout-Screening Scale (BOSS I) is a self-rating scale. All items are evaluated on a scale from 0 (‘not applicable’) to 5 (‘highly applicable’). For the global score (all items) three different scores were calculated: an intensity value as an average measure considering only applicable items, a relative width (originally “Breitenwert”) and a total average value as a measure for the average stress, Note: Due to the character of the study, no differentiation in primary and secondary outcome variables was intended. Because at least one primary end point is required to enter study results into the database, all outcome variables are presented using the end point type primary. Baseline is defined as the last measurement before first intake of study drug.

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	117
Units: points
arithmetic mean (standard deviation)	4.3 ± 0.61	3.45 ± 1.33

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

234

Analysis specification

Pre-specified

Analysis type

other ^[6]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-0.84

Confidence interval

level

95%

sides

2-sided

lower limit

-1.1

upper limit

-0.6

Variability estimate

Standard deviation

Dispersion value

1.2

Notes
[6] - Within-subject change between baseline and end of treatment

Primary: Change in global score total value of the Burnout Screening Scale (BOSS I) between baseline and end of treatment

Top of page

End point title

Change in global score total value of the Burnout Screening Scale (BOSS I) between baseline and end of treatment

End point description

The Burnout-Screening Scale (BOSS I) is a self-rating scale. All items are evaluated on a scale from 0 (‘not applicable’) to 5 (‘highly applicable’). For the global score (all items) three different scores were calculated: an intensity value as an average measure considering only applicable items, a relative width (originally “Breitenwert”) and a total average value as a measure for the average stress, Note: Due to the character of the study, no differentiation in primary and secondary outcome variables was intended. Because at least one primary end point is required to enter study results into the database, all outcome variables are presented using the end point type primary. Baseline is defined as the last measurement before first intake of study drug.

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	117
Units: points
arithmetic mean (standard deviation)	2.31 ± 0.82	1.44 ± 0.9

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

234

Analysis specification

Pre-specified

Analysis type

other ^[7]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-0.87

Confidence interval

level

95%

sides

2-sided

lower limit

-1

upper limit

-0.7

Variability estimate

Standard deviation

Dispersion value

0.88

Notes
[7] - Within-subject change between baseline and end of treatment

Primary: Change in intensity value of the Burnout Screening Scale (BOSS I) subscale profession between baseline and end of treatment

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End point title

Change in intensity value of the Burnout Screening Scale (BOSS I) subscale profession between baseline and end of treatment

End point description

The Burnout-Screening Scale (BOSS I) is a self-rating scale. All items are evaluated on a scale from 0 (‘not applicable’) to 5 (‘highly applicable’). For the subscale profession (10 items) three different scores were calculated: an intensity value as an average measure considering only applicable items, a relative width (originally “Breitenwert”) and a total average value as a measure for the average stress within the subscale. Note: Due to the character of the study, no differentiation in primary and secondary outcome variables was intended. Because at least one primary end point is required to enter study results into the database, all outcome variables are presented using the end point type primary. Baseline is defined as the last measurement before first intake of study drug.

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	114
Units: points
arithmetic mean (standard deviation)	2.43 ± 0.81	1.85 ± 0.71

Non-parametric analysis

Statistical analysis description

Baseline values available for 117 subjects, end of treatment values available for 114 subjects; LOCF; two-sided, confidence interval for mean difference is based on t-distribution evaluated for 114 subjects. The number of subjects included in analysis was summarized to 231 (Baseline 117, End of treatment 114) because of requirements of the Eudra-CT data base.

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

231

Analysis specification

Pre-specified

Analysis type

other ^[8]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-0.59

Confidence interval

level

95%

sides

2-sided

lower limit

-0.8

upper limit

-0.4

Variability estimate

Standard deviation

Dispersion value

0.86

Notes
[8] - Within-subject change between baseline and end of treatment

Primary: Change in relative width value of the Burnout Screening Scale (BOSS I) subscale profession between baseline and end of treatment

Top of page

End point title

Change in relative width value of the Burnout Screening Scale (BOSS I) subscale profession between baseline and end of treatment

End point description

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	117
Units: points
arithmetic mean (standard deviation)	3.98 ± 0.93	3.23 ± 1.46

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

234

Analysis specification

Pre-specified

Analysis type

other ^[9]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-0.76

Confidence interval

level

95%

sides

2-sided

lower limit

-1

upper limit

-0.5

Variability estimate

Standard deviation

Dispersion value

1.32

Notes
[9] - Within-subject change between baseline and end of treatment

Primary: Change in total value of the Burnout Screening Scale (BOSS I) subscale profession between baseline and end of treatment

Top of page

End point title

Change in total value of the Burnout Screening Scale (BOSS I) subscale profession between baseline and end of treatment

End point description

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	117
Units: points
arithmetic mean (standard deviation)	2 ± 0.93	1.29 ± 0.88

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

234

Analysis specification

Pre-specified

Analysis type

other ^[10]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-0.71

Confidence interval

level

95%

sides

2-sided

lower limit

-0.9

upper limit

-0.5

Variability estimate

Standard deviation

Dispersion value

0.98

Notes
[10] - Within-subject change between baseline and end of treatment

Primary: Change in intensity value of the Burnout Screening Scale (BOSS I) subscale person itself between baseline and end of treatment

Top of page

End point title

Change in intensity value of the Burnout Screening Scale (BOSS I) subscale person itself between baseline and end of treatment

End point description

The Burnout-Screening Scale (BOSS I) is a self-rating scale. All items are evaluated on a scale from 0 (‘not applicable’) to 5 (‘highly applicable’). For the subscale person itself (10 items) three different scores were calculated: an intensity value as an average measure considering only applicable items, a relative width (originally “Breitenwert”) and a total average value as a measure for the average stress within the subscale. Note: Due to the character of the study, no differentiation in primary and secondary outcome variables was intended. Because at least one primary end point is required to enter study results into the database, all outcome variables are presented using the end point type primary. Baseline is defined as the last measurement before first intake of study drug.

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	114
Units: points
arithmetic mean (standard deviation)	2.75 ± 0.82	1.92 ± 0.79

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

231

Analysis specification

Pre-specified

Analysis type

other ^[11]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-0.85

Confidence interval

level

95%

sides

2-sided

lower limit

-1

upper limit

-0.7

Variability estimate

Standard deviation

Dispersion value

0.93

Notes
[11] - Within-subject change between baseline and end of treatment

Primary: Change in relative width value of the Burnout Screening Scale (BOSS I) subscale person itself between baseline and end of treatment

Top of page

End point title

Change in relative width value of the Burnout Screening Scale (BOSS I) subscale person itself between baseline and end of treatment

End point description

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	117
Units: points
arithmetic mean (standard deviation)	4.46 ± 0.64	3.53 ± 1.44

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

234

Analysis specification

Pre-specified

Analysis type

other ^[12]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-0.93

Confidence interval

level

95%

sides

2-sided

lower limit

-1.2

upper limit

-0.7

Variability estimate

Standard deviation

Dispersion value

1.35

Notes
[12] - Within-subject change between baseline and end of treatment

Primary: Change in total value of the Burnout Screening Scale (BOSS I) subscale person itself between baseline and end of treatment

Top of page

End point title

Change in total value of the Burnout Screening Scale (BOSS I) subscale person itself between baseline and end of treatment

End point description

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	117
Units: points
arithmetic mean (standard deviation)	2.49 ± 0.91	1.47 ± 0.98

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

234

Analysis specification

Pre-specified

Analysis type

other ^[13]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-1.02

Confidence interval

level

95%

sides

2-sided

lower limit

-1.2

upper limit

-0.8

Variability estimate

Standard deviation

Dispersion value

1.02

Notes
[13] - Within-subject change between baseline and end of treatment

Primary: Change in intensity value of the Burnout Screening Scale (BOSS I) subscale family between baseline and end of treatment

Top of page

End point title

Change in intensity value of the Burnout Screening Scale (BOSS I) subscale family between baseline and end of treatment

End point description

The Burnout-Screening Scale (BOSS I) is a self-rating scale. All items are evaluated on a scale from 0 (‘not applicable’) to 5 (‘highly applicable’). For the subscale family (5 items) three different scores were calculated: an intensity value as an average measure considering only applicable items, a relative width (originally “Breitenwert”) and a total average value as a measure for the average stress within the subscale. Note: Due to the character of the study, no differentiation in primary and secondary outcome variables was intended. Because at least one primary end point is required to enter study results into the database, all outcome variables are presented using the end point type primary. Baseline is defined as the last measurement before first intake of study drug.

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	112
Units: points
arithmetic mean (standard deviation)	2.86 ± 0.94	2.22 ± 1.02

Non-parametric analysis

Statistical analysis description

Baseline values available for 117 subjects, end of treatment values available for 112 subjects; LOCF; two-sided, confidence interval for mean difference is based on t-distribution evaluated for 112 subjects. The number of subjects included in analysis was summarized to 229 (Baseline 117, End of treatment 112) because of requirements of the Eudra-CT data base.

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

229

Analysis specification

Pre-specified

Analysis type

other ^[14]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-0.66

Confidence interval

level

95%

sides

2-sided

lower limit

-0.9

upper limit

-0.5

Variability estimate

Standard deviation

Dispersion value

1.08

Notes
[14] - Within-subject change between baseline and end of treatment

Primary: Change in relative width value of the Burnout Screening Scale (BOSS I) subscale family between baseline and end of treatment

Top of page

End point title

Change in relative width value of the Burnout Screening Scale (BOSS I) subscale family between baseline and end of treatment

End point description

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	117
Units: points
arithmetic mean (standard deviation)	4.58 ± 0.7	3.77 ± 1.46

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

234

Analysis specification

Pre-specified

Analysis type

other ^[15]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-0.81

Confidence interval

level

95%

sides

2-sided

lower limit

-1.1

upper limit

-0.6

Variability estimate

Standard deviation

Dispersion value

1.39

Notes
[15] - Within-subject change between baseline and end of treatment

Primary: Change in total value of the Burnout Screening Scale (BOSS I) subscale family between baseline and end of treatment

Top of page

End point title

Change in total value of the Burnout Screening Scale (BOSS I) subscale family between baseline and end of treatment

End point description

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	117
Units: points
arithmetic mean (standard deviation)	2.66 ± 1.05	1.73 ± 1.1

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

234

Analysis specification

Pre-specified

Analysis type

other ^[16]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-0.93

Confidence interval

level

95%

sides

2-sided

lower limit

-1.1

upper limit

-0.7

Variability estimate

Standard deviation

Dispersion value

1.06

Notes
[16] - Within-subject change between baseline and end of treatment

Primary: Change in intensity value of the Burnout Screening Scale (BOSS I) subscale friends between baseline and end of treatment

Top of page

End point title

Change in intensity value of the Burnout Screening Scale (BOSS I) subscale friends between baseline and end of treatment

End point description

The Burnout-Screening Scale (BOSS I) is a self-rating scale. All items are evaluated on a scale from 0 (‘not applicable’) to 5 (‘highly applicable’). For the subscale friends (5 items) three different scores were calculated: an intensity value as an average measure considering only applicable items, a relative width (originally “Breitenwert”) and a total average value as a measure for the average stress within the subscale. Note: Due to the character of the study, no differentiation in primary and secondary outcome variables was intended. Because at least one primary end point is required to enter study results into the database, all outcome variables are presented using the end point type primary. Baseline is defined as the last measurement before first intake of study drug.

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	107
Units: points
arithmetic mean (standard deviation)	2.52 ± 0.9	1.92 ± 0.77

Non-parametric analysis

Statistical analysis description

Baseline values available for 117 subjects, end of treatment values available for 107 subjects; LOCF; two-sided, confidence interval for mean difference is based on t-distribution evaluated for 107 subjects. The number of subjects included in analysis was summarized to 224 (Baseline 117, End of treatment 107) because of requirements of the Eudra-CT data base.

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

224

Analysis specification

Pre-specified

Analysis type

other ^[17]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-0.65

Confidence interval

level

95%

sides

2-sided

lower limit

-0.8

upper limit

-0.5

Variability estimate

Standard deviation

Dispersion value

0.84

Notes
[17] - Within-subject change between baseline and end of treatment

Primary: Change in relative width value of the Burnout Screening Scale (BOSS I) subscale friends between baseline and end of treatment

Top of page

End point title

Change in relative width value of the Burnout Screening Scale (BOSS I) subscale friends between baseline and end of treatment

End point description

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	117
Units: points
arithmetic mean (standard deviation)	4.32 ± 0.97	3.44 ± 1.71

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

234

Analysis specification

Pre-specified

Analysis type

other ^[18]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-0.88

Confidence interval

level

95%

sides

2-sided

lower limit

-1.2

upper limit

-0.6

Variability estimate

Standard deviation

Dispersion value

1.62

Notes
[18] - Within-subject change between baseline and end of treatment

Primary: Change in total value of the Burnout Screening Scale (BOSS I) subscale friends between baseline and end of treatment

Top of page

End point title

Change in total value of the Burnout Screening Scale (BOSS I) subscale friends between baseline and end of treatment

End point description

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	117
Units: points
arithmetic mean (standard deviation)	2.25 ± 1.04	1.42 ± 1.03

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

234

Analysis specification

Pre-specified

Analysis type

other ^[19]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-0.84

Confidence interval

level

95%

sides

2-sided

lower limit

-1

upper limit

-0.7

Variability estimate

Standard deviation

Dispersion value

0.99

Notes
[19] - Within-subject change between baseline and end of treatment

Primary: Change in global score intensity value of the Burnout Screening Scale (BOSS II) between baseline and end of treatment

Top of page

End point title

Change in global score intensity value of the Burnout Screening Scale (BOSS II) between baseline and end of treatment

End point description

The Burnout-Screening Scale (BOSS II) is a self-rating scale. All items are evaluated on a scale from 0 (‘not applicable’) to 5 (‘highly applicable’). For the global score (all items) three different scores were calculated: an intensity value as an average measure considering only applicable items, a relative width (originally “Breitenwert”) and a total average value as a measure for the average stress. Note: Due to the character of the study, no differentiation in primary and secondary outcome variables was intended. Because at least one primary end point is required to enter study results into the database, all outcome variables are presented using the end point type primary. Baseline is defined as the last measurement before first intake of study drug.

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	114
Units: points
arithmetic mean (standard deviation)	2.47 ± 0.73	1.78 ± 0.62

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

231

Analysis specification

Pre-specified

Analysis type

other ^[20]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-0.71

Confidence interval

level

95%

sides

2-sided

lower limit

-0.8

upper limit

-0.6

Variability estimate

Standard deviation

Dispersion value

0.73

Notes
[20] - Within-subject change between baseline and end of treatment

Primary: Change in global score relative width value of the Burnout Screening Scale (BOSS II) between baseline and end of treatment

Top of page

End point title

Change in global score relative width value of the Burnout Screening Scale (BOSS II) between baseline and end of treatment

End point description

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	117
Units: points
arithmetic mean (standard deviation)	4.01 ± 0.79	3.04 ± 1.37

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

234

Analysis specification

Pre-specified

Analysis type

other ^[21]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-0.98

Confidence interval

level

95%

sides

2-sided

lower limit

-1.2

upper limit

-0.8

Variability estimate

Standard deviation

Dispersion value

1.22

Notes
[21] - Within-subject change between baseline and end of treatment

Primary: Change in global score total value of the Burnout Screening Scale (BOSS II) between baseline and end of treatment

Top of page

End point title

Change in global score total value of the Burnout Screening Scale (BOSS II) between baseline and end of treatment

End point description

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	117
Units: points
arithmetic mean (standard deviation)	2.05 ± 0.86	1.18 ± 0.81

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

234

Analysis specification

Pre-specified

Analysis type

other ^[22]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-0.87

Confidence interval

level

95%

sides

2-sided

lower limit

-1

upper limit

-0.7

Variability estimate

Standard deviation

Dispersion value

0.82

Notes
[22] - Within-subject change between baseline and end of treatment

Primary: Change in intensity value of the Burnout Screening Scale (BOSS II) subscale physical complaints between baseline and end of treatment

Top of page

End point title

Change in intensity value of the Burnout Screening Scale (BOSS II) subscale physical complaints between baseline and end of treatment

End point description

The Burnout-Screening Scale (BOSS II) is a self-rating scale. All items are evaluated on a scale from 0 (‘not applicable’) to 5 (‘highly applicable’). For the subscale physical complaints (10 items) three different scores were calculated: an intensity value as an average measure considering only applicable items, a relative width (originally “Breitenwert”) and a total average value as a measure for the average stress within the subscale. Note: Due to the character of the study, no differentiation in primary and secondary outcome variables was intended. Because at least one primary end point is required to enter study results into the database, all outcome variables are presented using the end point type primary. Baseline is defined as the last measurement before first intake of study drug.

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	112
Units: points
arithmetic mean (standard deviation)	2.46 ± 0.76	1.86 ± 0.64

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

229

Analysis specification

Pre-specified

Analysis type

other ^[23]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-0.63

Confidence interval

level

95%

sides

2-sided

lower limit

-0.8

upper limit

-0.5

Variability estimate

Standard deviation

Dispersion value

0.75

Notes
[23] - Within-subject change between baseline and end of treatment

Primary: Change in relative width value of the Burnout Screening Scale (BOSS II) subscale physical complaints between baseline and end of treatment

Top of page

End point title

Change in relative width value of the Burnout Screening Scale (BOSS II) subscale physical complaints between baseline and end of treatment

End point description

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	117
Units: points
arithmetic mean (standard deviation)	3.39 ± 1.09	2.52 ± 1.23

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

234

Analysis specification

Pre-specified

Analysis type

other ^[24]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-0.87

Confidence interval

level

95%

sides

2-sided

lower limit

-1.1

upper limit

-0.7

Variability estimate

Standard deviation

Dispersion value

1.16

Notes
[24] - Within-subject change between baseline and end of treatment

Primary: Change in total value of the Burnout Screening Scale (BOSS II) subscale physical complaints between baseline and end of treatment

Top of page

End point title

Change in total value of the Burnout Screening Scale (BOSS II) subscale physical complaints between baseline and end of treatment

End point description

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	117
Units: points
arithmetic mean (standard deviation)	1.69 ± 0.81	0.99 ± 0.7

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

234

Analysis specification

Pre-specified

Analysis type

other ^[25]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-0.7

Confidence interval

level

95%

sides

2-sided

lower limit

-0.8

upper limit

-0.6

Variability estimate

Standard deviation

Dispersion value

0.75

Notes
[25] - Within-subject change between baseline and end of treatment

Primary: Change in intensity value of the Burnout Screening Scale (BOSS II) subscale cognitive complaints between baseline and end of treatment

Top of page

End point title

Change in intensity value of the Burnout Screening Scale (BOSS II) subscale cognitive complaints between baseline and end of treatment

End point description

The Burnout-Screening Scale (BOSS II) is a self-rating scale. All items are evaluated on a scale from 0 (‘not applicable’) to 5 (‘highly applicable’). For the subscale cognitive complaints (10 items) three different scores were calculated: an intensity value as an average measure considering only applicable items, a relative width (originally “Breitenwert”) and a total average value as a measure for the average stress within the subscale. Note: Due to the character of the study, no differentiation in primary and secondary outcome variables was intended. Because at least one primary end point is required to enter study results into the database, all outcome variables are presented using the end point type primary. Baseline is defined as the last measurement before first intake of study drug.

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	112
Units: points
arithmetic mean (standard deviation)	2.47 ± 0.89	1.76 ± 0.74

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

229

Analysis specification

Pre-specified

Analysis type

other ^[26]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-0.74

Confidence interval

level

95%

sides

2-sided

lower limit

-0.9

upper limit

-0.6

Variability estimate

Standard deviation

Dispersion value

0.86

Notes
[26] - Within-subject change between baseline and end of treatment

Primary: Change in relative width value of the Burnout Screening Scale (BOSS II) subscale cognitive complaints between baseline and end of treatment

Top of page

End point title

Change in relative width value of the Burnout Screening Scale (BOSS II) subscale cognitive complaints between baseline and end of treatment

End point description

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	117
Units: points
arithmetic mean (standard deviation)	4.49 ± 0.8	3.48 ± 1.7

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

234

Analysis specification

Pre-specified

Analysis type

other ^[27]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-1.01

Confidence interval

level

95%

sides

2-sided

lower limit

-1.3

upper limit

-0.7

Variability estimate

Standard deviation

Dispersion value

1.61

Notes
[27] - Within-subject change between baseline and end of treatment

Primary: Change in total value of the Burnout Screening Scale (BOSS II) subscale cognitive complaints between baseline and end of treatment

Top of page

End point title

Change in total value of the Burnout Screening Scale (BOSS II) subscale cognitive complaints between baseline and end of treatment

End point description

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	117
Units: points
arithmetic mean (standard deviation)	2.29 ± 1.01	1.35 ± 1

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

234

Analysis specification

Pre-specified

Analysis type

other ^[28]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-0.95

Confidence interval

level

95%

sides

2-sided

lower limit

-1.1

upper limit

-0.8

Variability estimate

Standard deviation

Dispersion value

0.98

Notes
[28] - Within-subject change between baseline and end of treatment

Primary: Change in intensity value of the Burnout Screening Scale (BOSS II) subscale emotional complaints between baseline and end of treatment

Top of page

End point title

Change in intensity value of the Burnout Screening Scale (BOSS II) subscale emotional complaints between baseline and end of treatment

End point description

The Burnout-Screening Scale (BOSS II) is a self-rating scale. All items are evaluated on a scale from 0 (‘not applicable’) to 5 (‘highly applicable’). For the subscale emotional complaints (10 items) three different scores were calculated: an intensity value as an average measure considering only applicable items, a relative width (originally “Breitenwert”) and a total average value as a measure for the average stress within the subscale. Note: Due to the character of the study, no differentiation in primary and secondary outcome variables was intended. Because at least one primary end point is required to enter study results into the database, all outcome variables are presented using the end point type primary. Baseline is defined as the last measurement before first intake of study drug.

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	109
Units: points
arithmetic mean (standard deviation)	2.46 ± 0.87	1.71 ± 0.75

Non-parametric analysis

Statistical analysis description

Baseline values available for 117 subjects, end of treatment values available for 109 subjects; LOCF; two-sided, confidence interval for mean difference is based on t-distribution evaluated for 109 subjects. The number of subjects included in analysis was summarized to 226 (Baseline 117, End of treatment 109) because of requirements of the Eudra-CT data base.

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

226

Analysis specification

Pre-specified

Analysis type

other ^[29]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-0.78

Confidence interval

level

95%

sides

2-sided

lower limit

-0.9

upper limit

-0.6

Variability estimate

Standard deviation

Dispersion value

0.86

Notes
[29] - Within-subject change between baseline and end of treatment

Primary: Change in relative width value of the Burnout Screening Scale (BOSS II) subscale emotional complaints between baseline and end of treatment

Top of page

End point title

Change in relative width value of the Burnout Screening Scale (BOSS II) subscale emotional complaints between baseline and end of treatment

End point description

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	117
Units: points
arithmetic mean (standard deviation)	4.16 ± 1.13	3.11 ± 1.69

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

234

Analysis specification

Pre-specified

Analysis type

other ^[30]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-1.05

Confidence interval

level

95%

sides

2-sided

lower limit

-1.3

upper limit

-0.8

Variability estimate

Standard deviation

Dispersion value

1.57

Notes
[30] - Within-subject change between baseline and end of treatment

Primary: Change in total value of the Burnout Screening Scale (BOSS II) subscale emotional complaints between baseline and end of treatment

Top of page

End point title

Change in total value of the Burnout Screening Scale (BOSS II) subscale emotional complaints between baseline and end of treatment

End point description

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	117
Units: points
arithmetic mean (standard deviation)	2.16 ± 1.1	1.19 ± 1

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

234

Analysis specification

Pre-specified

Analysis type

other ^[31]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-0.97

Confidence interval

level

95%

sides

2-sided

lower limit

-1.2

upper limit

-0.8

Variability estimate

Standard deviation

Dispersion value

1.02

Notes
[31] - Within-subject change between baseline and end of treatment

Primary: Change in time of the Numbers Connecting Test (ZVT) between baseline and end of treatment

Top of page

End point title

Change in time of the Numbers Connecting Test (ZVT) between baseline and end of treatment

End point description

The Numbers Connecting Test consists of four tests A, B, C, and D. In each test, the time in seconds is recorded that a subject needed to complete the test. The average time for all four tests of each subject was used for evaluation. Note: Due to the character of the study, no differentiation in primary and secondary outcome variables was intended. Because at least one primary end point is required to enter study results into the database, all outcome variables are presented using the end point type primary. Baseline is defined as the last measurement before first intake of study drug.

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	117
Units: time in seconds
arithmetic mean (standard deviation)	72.62 ± 19.55	60.54 ± 15.79

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

234

Analysis specification

Pre-specified

Analysis type

other ^[32]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-12.07

Confidence interval

level

95%

sides

2-sided

lower limit

-13.8

upper limit

-10.4

Variability estimate

Standard deviation

Dispersion value

9.24

Notes
[32] - Within-subject change between baseline and end of treatment

Primary: Change in subjective stress symptom anxiety assessed on a numerical analogue scale between baseline and end of treatment

Top of page

End point title

Change in subjective stress symptom anxiety assessed on a numerical analogue scale between baseline and end of treatment

End point description

The subjective stress symptom was recorded on a numerical analogue scale which ranges from 0 (‘not impaired at all’) to 10 (‘severely impaired’). Note: Due to the character of the study, no differentiation in primary and secondary outcome variables was intended. Because at least one primary end point is required to enter study results into the database, all outcome variables are presented using the end point type primary. Baseline is defined as the last measurement before first intake of study drug.

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	117
Units: points
arithmetic mean (standard deviation)	4.45 ± 2.5	2.69 ± 2.55

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

234

Analysis specification

Pre-specified

Analysis type

other ^[33]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-1.76

Confidence interval

level

95%

sides

2-sided

lower limit

-2.3

upper limit

-1.2

Variability estimate

Standard deviation

Dispersion value

3.02

Notes
[33] - Within-subject change between baseline and end of treatment

Primary: Change in subjective stress symptom exhaustion assessed on a numerical analogue acale between baseline and end of treatment

Top of page

End point title

Change in subjective stress symptom exhaustion assessed on a numerical analogue acale between baseline and end of treatment

End point description

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	117
Units: points
arithmetic mean (standard deviation)	6.93 ± 1.59	3.8 ± 2.75

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

234

Analysis specification

Pre-specified

Analysis type

other ^[34]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-3.14

Confidence interval

level

95%

sides

2-sided

lower limit

-3.7

upper limit

-2.6

Variability estimate

Standard deviation

Dispersion value

2.83

Notes
[34] - Within-subject change between baseline and end of treatment

Primary: Change in subjective stress symptom feeling of heteronomy assessed on a numerical analogue scale between baseline and end of treatment

Top of page

End point title

Change in subjective stress symptom feeling of heteronomy assessed on a numerical analogue scale between baseline and end of treatment

End point description

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	117
Units: points
arithmetic mean (standard deviation)	4.19 ± 2.72	2.47 ± 2.52

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

234

Analysis specification

Pre-specified

Analysis type

other ^[35]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-1.72

Confidence interval

level

95%

sides

2-sided

lower limit

-2.2

upper limit

-1.2

Variability estimate

Standard deviation

Dispersion value

2.89

Notes
[35] - Within-subject change between baseline and end of treatment

Primary: Change in subjective stress symptom impairment of concentration assessed on a numerical analogue scale between baseline and end of treatment

Top of page

End point title

Change in subjective stress symptom impairment of concentration assessed on a numerical analogue scale between baseline and end of treatment

End point description

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	117
Units: points
arithmetic mean (standard deviation)	5.79 ± 1.97	3.31 ± 2.6

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

234

Analysis specification

Pre-specified

Analysis type

other ^[36]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-2.48

Confidence interval

level

95%

sides

2-sided

lower limit

-3

upper limit

-2

Variability estimate

Standard deviation

Dispersion value

2.62

Notes
[36] - Within-subject change between baseline and end of treatment

Primary: Change in subjective stress symptom irritability assessed on a numerical analogue scale between baseline and end of treatment

Top of page

End point title

Change in subjective stress symptom irritability assessed on a numerical analogue scale between baseline and end of treatment

End point description

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	117
Units: points
arithmetic mean (standard deviation)	5.53 ± 2.21	3.23 ± 2.53

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

234

Analysis specification

Pre-specified

Analysis type

other ^[37]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-2.29

Confidence interval

level

95%

sides

2-sided

lower limit

-2.8

upper limit

-1.8

Variability estimate

Standard deviation

Dispersion value

2.76

Notes
[37] - Within-subject change between baseline and end of treatment

Primary: Change in subjective stress symptom loss of zest for life assessed on a numerical analogue scale between baseline and end of treatment

Top of page

End point title

Change in subjective stress symptom loss of zest for life assessed on a numerical analogue scale between baseline and end of treatment

End point description

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	117
Units: points
arithmetic mean (standard deviation)	4.76 ± 2.47	2.61 ± 2.52

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

234

Analysis specification

Pre-specified

Analysis type

other ^[38]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-2.15

Confidence interval

level

95%

sides

2-sided

lower limit

-2.6

upper limit

-1.7

Variability estimate

Standard deviation

Dispersion value

2.55

Notes
[38] - Within-subject change between baseline and end of treatment

Primary: Change in subjective stress somatic symptoms assessed on a numerical analogue scale between baseline and end of treatment

Top of page

End point title

Change in subjective stress somatic symptoms assessed on a numerical analogue scale between baseline and end of treatment

End point description

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	117
Units: points
arithmetic mean (standard deviation)	5.75 ± 2.06	3.33 ± 2.61

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

234

Analysis specification

Pre-specified

Analysis type

other ^[39]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-2.41

Confidence interval

level

95%

sides

2-sided

lower limit

-2.9

upper limit

-2

Variability estimate

Standard deviation

Dispersion value

2.5

Notes
[39] - Within-subject change between baseline and end of treatment

Primary: Change in score of subjective stress symptoms assessed on a numerical analogue scale between baseline and end of treatment

Top of page

End point title

Change in score of subjective stress symptoms assessed on a numerical analogue scale between baseline and end of treatment

End point description

Seven items of subjective stress symptoms were assessed on numerical analogue scales which range from 0 ('not impaired at all') to 10 ('severely impaired'). The sum of all subjective stress symptom items/7 was evaluated as a total score for subjective stress symptoms. Note: Due to the character of the study, no differentiation in primary and secondary outcome variables was intended. Because at least one primary end point is required to enter study results into the database, all outcome variables are presented using the end point type primary. Baseline is defined as the last measurement before first intake of study drug.

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	117
Units: points
arithmetic mean (standard deviation)	5.34 ± 1.22	3.06 ± 2.12

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

234

Analysis specification

Pre-specified

Analysis type

other ^[40]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-2.28

Confidence interval

level

95%

sides

2-sided

lower limit

-2.6

upper limit

-1.9

Variability estimate

Standard deviation

Dispersion value

1.98

Notes
[40] - Within-subject change between baseline and end of treatment

Primary: Change in numerical analogue scale for impairment of sexual life between baseline and end of treatment

Top of page

End point title

Change in numerical analogue scale for impairment of sexual life between baseline and end of treatment

End point description

The numerical analogue scale (NAS) for Impairment of Sexual Life is a single item (overall satisfaction with sexual life) and ranges from 0 (‘not impaired at all’) to 10 (‘severely impaired’). Note: Due to the character of the study, no differentiation in primary and secondary outcome variables was intended. Because at least one primary end point is required to enter study results into the database, all outcome variables are presented using the end point type primary. Baseline is defined as the last measurement before first intake of study drug.

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	117
Units: points
arithmetic mean (standard deviation)	6.8 ± 1.53	4.17 ± 3.09

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

234

Analysis specification

Pre-specified

Analysis type

other ^[41]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-2.63

Confidence interval

level

95%

sides

2-sided

lower limit

-3.1

upper limit

-2.1

Variability estimate

Standard deviation

Dispersion value

2.81

Notes
[41] - Within-subject change between baseline and end of treatment

Primary: Change in rating of the Patient Sexual Function Questionnaire (PSFQ) item ‘thinking about sex with interest / desire‘ between baseline and end of treatment

Top of page

End point title

Change in rating of the Patient Sexual Function Questionnaire (PSFQ) item ‘thinking about sex with interest / desire‘ between baseline and end of treatment

End point description

A 7-point scale was provided in order to rate the change compared to the reference state from 1 (‘absent’ or ‘greatly reduced’) to 7 (‘greatly increased’), or a ‘not applicable’ answer is given instead. Note: Due to the character of the study, no differentiation in primary and secondary outcome variables was intended. Because at least one primary end point is required to enter study results into the database, all outcome variables are presented using the end point type primary. Baseline is defined as the last measurement before first intake of study drug.

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	116	116
Units: points
arithmetic mean (standard deviation)	2.72 ± 1.51	3.32 ± 1.4

Non-parametric analysis

Statistical analysis description

Baseline values available for 116 subjects, end of treatment values available for 116 subjects; LOCF; two-sided, confidence interval for mean difference is based on t-distribution evaluated for 116 subjects. The number of subjects included in analysis was summarized to 232 (Baseline 116, End of treatment 116) because of requirements of the Eudra-CT data base.

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

232

Analysis specification

Pre-specified

Analysis type

other ^[42]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

0.6

Confidence interval

level

95%

sides

2-sided

lower limit

0.4

upper limit

0.8

Variability estimate

Standard deviation

Dispersion value

1.33

Notes
[42] - Within-subject change between baseline and end of treatment

Primary: Change in rating of the Patient Sexual Function Questionnaire (PSFQ) item ‘enjoyment of sex‘ between baseline and end of treatment

Top of page

End point title

Change in rating of the Patient Sexual Function Questionnaire (PSFQ) item ‘enjoyment of sex‘ between baseline and end of treatment

End point description

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	115	112
Units: points
arithmetic mean (standard deviation)	2.63 ± 1.28	3.25 ± 1.33

Non-parametric analysis

Statistical analysis description

Baseline values available for 115 subjects, end of treatment values available for 112 subjects; LOCF; two-sided, confidence interval for mean difference is based on t-distribution evaluated for 112 subjects. The number of subjects included in analysis was summarized to 227 (Baseline 115, End of treatment 112) because of requirements of the Eudra-CT data base.

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

227

Analysis specification

Pre-specified

Analysis type

other ^[43]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

0.59

Confidence interval

level

95%

sides

2-sided

lower limit

0.3

upper limit

0.8

Variability estimate

Standard deviation

Dispersion value

1.3

Notes
[43] - Within-subject change between baseline and end of treatment

Primary: Change in rating of the Patient Sexual Function Questionnaire (PSFQ) item ‘ability to become sexually aroused‘ between baseline and end of treatment

Top of page

End point title

Change in rating of the Patient Sexual Function Questionnaire (PSFQ) item ‘ability to become sexually aroused‘ between baseline and end of treatment

End point description

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	116	114
Units: points
arithmetic mean (standard deviation)	2.85 ± 1.36	3.38 ± 1.24

Non-parametric analysis

Statistical analysis description

Baseline values available for 116 subjects, end of treatment values available for 114 subjects; LOCF; two-sided, confidence interval for mean difference is based on t-distribution evaluated for 114 subjects. The number of subjects included in analysis was summarized to 230 (Baseline 116, End of treatment 114) because of requirements of the Eudra-CT data base.

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

230

Analysis specification

Pre-specified

Analysis type

other ^[44]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

0.51

Confidence interval

level

95%

sides

2-sided

lower limit

0.3

upper limit

0.7

Variability estimate

Standard deviation

Dispersion value

1.3

Notes
[44] - Within-subject change between baseline and end of treatment

Primary: Change in rating of the Patient Sexual Function Questionnaire (PSFQ) item ‘frequency of sexual activity‘ between baseline and end of treatment

Top of page

End point title

Change in rating of the Patient Sexual Function Questionnaire (PSFQ) item ‘frequency of sexual activity‘ between baseline and end of treatment

End point description

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	115	113
Units: points
arithmetic mean (standard deviation)	2.17 ± 1.21	2.81 ± 1.4

Non-parametric analysis

Statistical analysis description

Baseline values available for 115 subjects, end of treatment values available for 113 subjects; LOCF; two-sided, confidence interval for mean difference is based on t-distribution evaluated for 113 subjects. The number of subjects included in analysis was summarized to 228 (Baseline 115, End of treatment 113) because of requirements of the Eudra-CT data base.

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

228

Analysis specification

Pre-specified

Analysis type

other ^[45]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

0.63

Confidence interval

level

95%

sides

2-sided

lower limit

0.4

upper limit

0.9

Variability estimate

Standard deviation

Dispersion value

1.28

Notes
[45] - Within-subject change between baseline and end of treatment

Primary: Change in rating of the Patient Sexual Function Questionnaire (PSFQ) item ‘ability to have orgasm‘ between baseline and end of treatment

Top of page

End point title

Change in rating of the Patient Sexual Function Questionnaire (PSFQ) item ‘ability to have orgasm‘ between baseline and end of treatment

End point description

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	116	114
Units: points
arithmetic mean (standard deviation)	2.98 ± 1.27	3.27 ± 1.15

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

230

Analysis specification

Pre-specified

Analysis type

other ^[46]

P-value

= 0.0052

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

0.28

Confidence interval

level

95%

sides

2-sided

lower limit

0.1

upper limit

0.5

Variability estimate

Standard deviation

Dispersion value

1.05

Notes
[46] - Within-subject change between baseline and end of treatment

Primary: Change in rating of the Patient Sexual Function Questionnaire (PSFQ) item ‘overall satisfaction with sexual life‘ between baseline and end of treatment

Top of page

End point title

Change in rating of the Patient Sexual Function Questionnaire (PSFQ) item ‘overall satisfaction with sexual life‘ between baseline and end of treatment

End point description

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	113	114
Units: points
arithmetic mean (standard deviation)	2.5 ± 1.09	3.15 ± 1.2

Non-parametric analysis

Statistical analysis description

Baseline values available for 113 subjects, end of treatment values available for 114 subjects; LOCF; two-sided, confidence interval for mean difference is based on t-distribution evaluated for 112 subjects. The number of subjects included in analysis was summarized to 227 (Baseline 113, End of treatment 114) because of requirements of the Eudra-CT data base.

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

227

Analysis specification

Pre-specified

Analysis type

other ^[47]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

0.63

Confidence interval

level

95%

sides

2-sided

lower limit

0.4

upper limit

0.9

Variability estimate

Standard deviation

Dispersion value

1.23

Notes
[47] - Within-subject change between baseline and end of treatment

Primary: Change in rating of the Patient Sexual Function Questionnaire (PSFQ) item ‘ability to have and/or maintain an erection‘ between baseline and end of treatment

Top of page

End point title

Change in rating of the Patient Sexual Function Questionnaire (PSFQ) item ‘ability to have and/or maintain an erection‘ between baseline and end of treatment

End point description

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	49 ^[48]	49 ^[49]
Units: points
arithmetic mean (standard deviation)	3.22 ± 0.94	3.63 ± 0.88

Notes
[48] - only male subjects
[49] - only male subjects

Non-parametric analysis

Statistical analysis description

Baseline values available for 49 male subjects, end of treatment values available for 49 male subjects; LOCF; two-sided, confidence interval for mean difference is based on t-distribution evaluated for 49 male subjects. The number of subjects included in analysis was summarized to 98 (Baseline 49, End of treatment 49) because of requirements of the Eudra-CT data base.

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[50]

P-value

= 0.0015

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

0.41

Confidence interval

level

95%

sides

2-sided

lower limit

0.2

upper limit

0.6

Variability estimate

Standard deviation

Dispersion value

0.81

Notes
[50] - Within-subject change between baseline and end of treatment

Primary: Change in rating of the Patient Sexual Function Questionnaire (PSFQ) item ‘ability to ejaculate‘ between baseline and end of treatment

Top of page

End point title

Change in rating of the Patient Sexual Function Questionnaire (PSFQ) item ‘ability to ejaculate‘ between baseline and end of treatment

End point description

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	49 ^[51]	49 ^[52]
Units: points
arithmetic mean (standard deviation)	3.65 ± 0.86	3.69 ± 0.71

Notes
[51] - only male subjects
[52] - only male subjects

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

other ^[53]

P-value

= 0.7449

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

0.04

Confidence interval

level

95%

sides

2-sided

lower limit

-0.2

upper limit

0.2

Variability estimate

Standard deviation

Dispersion value

0.68

Notes
[53] - Within-subject change between baseline and end of treatment

Primary: Change in rating of the Patient Sexual Function Questionnaire (PSFQ) item ‘relevance of sexual functioning for current wellbeing‘ between baseline and end of treatment

Top of page

End point title

Change in rating of the Patient Sexual Function Questionnaire (PSFQ) item ‘relevance of sexual functioning for current wellbeing‘ between baseline and end of treatment

End point description

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	117
Units: points
arithmetic mean (standard deviation)	3.85 ± 1.44	3.77 ± 1.59

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

234

Analysis specification

Pre-specified

Analysis type

other ^[54]

P-value

= 0.6093

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-0.09

Confidence interval

level

95%

sides

2-sided

lower limit

-0.4

upper limit

0.2

Variability estimate

Standard deviation

Dispersion value

1.72

Notes
[54] - Within-subject change between baseline and end of treatment

Primary: Change in Perceived Stress Questionnaire (PSQ) stress score between baseline and end of treatment

Top of page

End point title

Change in Perceived Stress Questionnaire (PSQ) stress score between baseline and end of treatment

End point description

The Perceived Stress Questionnaire (PSQ) contains 30 questions. The person rates whether a statement is true on scale which ranges from 1 (‘almost never’) to 4 (‘usually’). For the calculation of scores for the seven subscales and the stress score the items 01, 07, 10, 13, 17, 21, 25, and 29 will be reversed according to their positive assessment by calculating 5 minus item value. The PSQ stress score is calculated as: (sum of all items - 30) / 90 Note: Due to the character of the study, no differentiation in primary and secondary outcome variables was intended. Because at least one primary end point is required to enter study results into the database, all outcome variables are presented using the end point type primary. Baseline is defined as the last measurement before first intake of study drug.

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	117
Units: points
arithmetic mean (standard deviation)	0.6 ± 0.15	0.44 ± 0.2

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

234

Analysis specification

Pre-specified

Analysis type

other ^[55]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-0.15

Confidence interval

level

95%

sides

2-sided

lower limit

-0.2

upper limit

-0.1

Variability estimate

Standard deviation

Dispersion value

0.18

Notes
[55] - Within-subject change between baseline and end of treatment

Primary: Change in Perceived Stress Questionnaire (PSQ) subscale fatigue between baseline and end of treatment

Top of page

End point title

Change in Perceived Stress Questionnaire (PSQ) subscale fatigue between baseline and end of treatment

End point description

The Perceived Stress Questionnaire (PSQ) contains 30 questions. The person rates whether a statement is true on scale which ranges from 1 (‘almost never’) to 4 (‘usually’). For the calculation of scores for the seven subscales and the stress score the items 01, 07, 10, 13, 17, 21, 25, and 29 will be reversed according to their positive assessment by calculating 5 minus item value. The subscale fatigue is calculated as the sum of the items 01; 08; 13; 15. Note: Due to the character of the study, no differentiation in primary and secondary outcome variables was intended. Because at least one primary end point is required to enter study results into the database, all outcome variables are presented using the end point type primary. Baseline is defined as the last measurement before first intake of study drug.

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	117
Units: points
arithmetic mean (standard deviation)	12.47 ± 2.14	10.06 ± 3.08

Non-parametric analysis

Statistical analysis description

Comparison groups

Rhodiola rosea extract (Rosalin) v Baseline

Number of subjects included in analysis

234

Analysis specification

Pre-specified

Analysis type

other ^[56]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-2.41

Confidence interval

level

95%

sides

2-sided

lower limit

-3

upper limit

-1.9

Variability estimate

Standard deviation

Dispersion value

3.03

Notes
[56] - Within-subject change between baseline and end of treatment

Primary: Change in Perceived Stress Questionnaire (PSQ) subscale harassment between baseline and end of treatment

Top of page

End point title

Change in Perceived Stress Questionnaire (PSQ) subscale harassment between baseline and end of treatment

End point description

The Perceived Stress Questionnaire (PSQ) contains 30 questions. The person rates whether a statement is true on scale which ranges from 1 (‘almost never’) to 4 (‘usually’). For the calculation of scores for the seven subscales and the stress score the items 01, 07, 10, 13, 17, 21, 25, and 29 will be reversed according to their positive assessment by calculating 5 minus item value. The subscale harassment is calculated as the sum of the items 02; 06; 19; 24. Note: Due to the character of the study, no differentiation in primary and secondary outcome variables was intended. Because at least one primary end point is required to enter study results into the database, all outcome variables are presented using the end point type primary. Baseline is defined as the last measurement before first intake of study drug.

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	117
Units: points
arithmetic mean (standard deviation)	10.05 ± 2.34	8.56 ± 2.62

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

234

Analysis specification

Pre-specified

Analysis type

other ^[57]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-1.5

Confidence interval

level

95%

sides

2-sided

lower limit

-2

upper limit

-1

Variability estimate

Standard deviation

Dispersion value

2.52

Notes
[57] - Within-subject change between baseline and end of treatment

Primary: Change in Perceived Stress Questionnaire (PSQ) subscale irritability between baseline and end of treatment

Top of page

End point title

Change in Perceived Stress Questionnaire (PSQ) subscale irritability between baseline and end of treatment

End point description

The Perceived Stress Questionnaire (PSQ) contains 30 questions. The person rates whether a statement is true on scale which ranges from 1 (‘almost never’) to 4 (‘usually’). For the calculation of scores for the seven subscales and the stress score the items 01, 07, 10, 13, 17, 21, 25, and 29 will be reversed according to their positive assessment by calculating 5 minus item value. The subscale irritability is calculated as the sum of the items 03; 10. Note: Due to the character of the study, no differentiation in primary and secondary outcome variables was intended. Because at least one primary end point is required to enter study results into the database, all outcome variables are presented using the end point type primary. Baseline is defined as the last measurement before first intake of study drug.

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	117
Units: points
arithmetic mean (standard deviation)	5.73 ± 1.34	4.63 ± 1.56

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

234

Analysis specification

Pre-specified

Analysis type

other ^[58]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-1.09

Confidence interval

level

95%

sides

2-sided

lower limit

-1.4

upper limit

-0.8

Variability estimate

Standard deviation

Dispersion value

1.53

Notes
[58] - Within-subject change between baseline and end of treatment

Primary: Change in Perceived Stress Questionnaire (PSQ) subscale lack of joy between baseline and end of treatment

Top of page

End point title

Change in Perceived Stress Questionnaire (PSQ) subscale lack of joy between baseline and end of treatment

End point description

The Perceived Stress Questionnaire (PSQ) contains 30 questions. The person rates whether a statement is true on scale which ranges from 1 (‘almost never’) to 4 (‘usually’). For the calculation of scores for the seven subscales and the stress score the items 01, 07, 10, 13, 17, 21, 25, and 29 will be reversed according to their positive assessment by calculating 5 minus item value. The subscale lack of joy is calculated as the sum of the items 05; 07; 16; 17; 21; 23; 25. Note: Due to the character of the study, no differentiation in primary and secondary outcome variables was intended. Because at least one primary end point is required to enter study results into the database, all outcome variables are presented using the end point type primary. Baseline is defined as the last measurement before first intake of study drug.

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	117
Units: points
arithmetic mean (standard deviation)	19.26 ± 3.69	16.49 ± 4.59

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

234

Analysis specification

Pre-specified

Analysis type

other ^[59]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-2.78

Confidence interval

level

95%

sides

2-sided

lower limit

-3.5

upper limit

-2

Variability estimate

Standard deviation

Dispersion value

4.14

Notes
[59] - Within-subject change between baseline and end of treatment

Primary: Change in Perceived Stress Questionnaire (PSQ) subscale overload between baseline and end of treatment

Top of page

End point title

Change in Perceived Stress Questionnaire (PSQ) subscale overload between baseline and end of treatment

End point description

The Perceived Stress Questionnaire (PSQ) contains 30 questions. The person rates whether a statement is true on scale which ranges from 1 (‘almost never’) to 4 (‘usually’). For the calculation of scores for the seven subscales and the stress score the items 01, 07, 10, 13, 17, 21, 25, and 29 will be reversed according to their positive assessment by calculating 5 minus item value. The subscale overload is calculated as the sum of the items 04; 11; 28; 29 Note: Due to the character of the study, no differentiation in primary and secondary outcome variables was intended. Because at least one primary end point is required to enter study results into the database, all outcome variables are presented using the end point type primary. Baseline is defined as the last measurement before first intake of study drug.

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	117
Units: points
arithmetic mean (standard deviation)	11.57 ± 2.62	10.21 ± 2.89

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

234

Analysis specification

Pre-specified

Analysis type

other ^[60]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-1.36

Confidence interval

level

95%

sides

2-sided

lower limit

-1.8

upper limit

-0.9

Variability estimate

Standard deviation

Dispersion value

2.32

Notes
[60] - Within-subject change between baseline and end of treatment

Primary: Change in Perceived Stress Questionnaire (PSQ) subscale tension between baseline and end of treatment

Top of page

End point title

Change in Perceived Stress Questionnaire (PSQ) subscale tension between baseline and end of treatment

End point description

The Perceived Stress Questionnaire (PSQ) contains 30 questions. The person rates whether a statement is true on scale which ranges from 1 (‘almost never’) to 4 (‘usually’). For the calculation of scores for the seven subscales and the stress score the items 01, 07, 10, 13, 17, 21, 25, and 29 will be reversed according to their positive assessment by calculating 5 minus item value. The subscale tension is calculated as the sum of the items 12; 14; 26; 27. Note: Due to the character of the study, no differentiation in primary and secondary outcome variables was intended. Because at least one primary end point is required to enter study results into the database, all outcome variables are presented using the end point type primary. Baseline is defined as the last measurement before first intake of study drug.

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	117
Units: points
arithmetic mean (standard deviation)	11.74 ± 2.09	9.32 ± 2.96

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

234

Analysis specification

Pre-specified

Analysis type

other ^[61]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-2.41

Confidence interval

level

95%

sides

2-sided

lower limit

-2.9

upper limit

-1.9

Variability estimate

Standard deviation

Dispersion value

2.6

Notes
[61] - Within-subject change between baseline and end of treatment

Primary: Change in Perceived Stress Questionnaire (PSQ) subscale worries between baseline and end of treatment

Top of page

End point title

Change in Perceived Stress Questionnaire (PSQ) subscale worries between baseline and end of treatment

End point description

The Perceived Stress Questionnaire (PSQ) contains 30 questions. The person rates whether a statement is true on scale which ranges from 1 (‘almost never’) to 4 (‘usually’). For the calculation of scores for the seven subscales and the stress score the items 01, 07, 10, 13, 17, 21, 25, and 29 will be reversed according to their positive assessment by calculating 5 minus item value. The subscale worries is calculated as the sum of the items 09; 18; 20; 22; 30. Note: Due to the character of the study, no differentiation in primary and secondary outcome variables was intended. Because at least one primary end point is required to enter study results into the database, all outcome variables are presented using the end point type primary. Baseline is defined as the last measurement before first intake of study drug.

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	117
Units: points
arithmetic mean (standard deviation)	12.86 ± 3.08	10.74 ± 3.25

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

234

Analysis specification

Pre-specified

Analysis type

other ^[62]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-2.12

Confidence interval

level

95%

sides

2-sided

lower limit

-2.7

upper limit

-1.5

Variability estimate

Standard deviation

Dispersion value

3.21

Notes
[62] - Within-subject change between baseline and end of treatment

Primary: Change in global impairment score of the Sheehan Disability Scale between baseline and end of treatment

Top of page

End point title

Change in global impairment score of the Sheehan Disability Scale between baseline and end of treatment

End point description

The Sheehan Disability Scale is a brief self-report (patient-rated) inventory. All items are scored on a 0-10 scale, where 0 represents no impairment, 1-3 mild impairment, 4-6 moderate impairment, 7-9 marked impairment and 10 extreme impairments. A total score named “global impairment” is calculated as the sum of the first three items of the questionnaire. Note: Due to the character of the study, no differentiation in primary and secondary outcome variables was intended. Because at least one primary end point is required to enter study results into the database, all outcome variables are presented using the end point type primary. Baseline is defined as the last measurement before first intake of study drug.

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	117
Units: points
arithmetic mean (standard deviation)	17.83 ± 5.76	12.39 ± 7.7

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

234

Analysis specification

Pre-specified

Analysis type

other ^[63]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-5.44

Confidence interval

level

95%

sides

2-sided

lower limit

-6.7

upper limit

-4.2

Variability estimate

Standard deviation

Dispersion value

6.91

Notes
[63] - Within-subject change between baseline and end of treatment

Primary: Change in Sheehan Disability Scale item ‘days lost’ between baseline and end of treatment

Top of page

End point title

Change in Sheehan Disability Scale item ‘days lost’ between baseline and end of treatment

End point description

The Sheehan Disability Scale is a brief self-report (patient-rated) inventory. All items are scored on a 0-10 scale, where 0 represents no impairment, 1-3 mild impairment, 4-6 moderate impairment, 7-9 marked impairment and 10 extreme impairments. Note: Due to the character of the study, no differentiation in primary and secondary outcome variables was intended. Because at least one primary end point is required to enter study results into the database, all outcome variables are presented using the end point type primary. Baseline is defined as the last measurement before first intake of study drug.

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	117
Units: points
arithmetic mean (standard deviation)	1 ± 2.32	0.57 ± 1.34

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

234

Analysis specification

Pre-specified

Analysis type

other ^[64]

P-value

= 0.0628

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-0.42

Confidence interval

level

95%

sides

2-sided

lower limit

-0.8

upper limit

Variability estimate

Standard deviation

Dispersion value

2.12

Notes
[64] - Within-subject change between baseline and end of treatment

Primary: Change in Sheehan Disability Scale item ‘days underproductive’ between baseline and end of treatment

Top of page

End point title

Change in Sheehan Disability Scale item ‘days underproductive’ between baseline and end of treatment

End point description

The Sheehan Disability Scale is a brief self-report (patient-rated) inventory. All items are scored on a 0-10 scale, where 0 represents no impairment, 1-3 mild impairment, 4-6 moderate impairment, 7-9 marked impairment and 10 extreme impairments. Note: Due to the character of the study, no differentiation in primary and secondary outcome variables was intended. Because at least one primary end point is required to enter study results into the database, all outcome variables are presented using the end point type primary. Baseline is defined as the last measurement before first intake of study drug.

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	117
Units: points
arithmetic mean (standard deviation)	2.52 ± 2.38	1.47 ± 1.75

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

234

Analysis specification

Pre-specified

Analysis type

other ^[65]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-1.05

Confidence interval

level

95%

sides

2-sided

lower limit

-1.5

upper limit

-0.6

Variability estimate

Standard deviation

Dispersion value

2.47

Notes
[65] - Within-subject change between baseline and end of treatment

Primary: Change in Multidimensional Mood State Questionnaire (MDMQ) subscale 'alertness – tiredness' between baseline and end of treatment

Top of page

End point title

Change in Multidimensional Mood State Questionnaire (MDMQ) subscale 'alertness – tiredness' between baseline and end of treatment

End point description

The Multidimensional Mood State Questionnaire is a self-rating scale to describe three dimensions of mood and wellbeing. Each subscale consists of four adjectives representing the positive and four adjectives representing the negative aspect. Each adjective is rated on a five-point scale ranging from 1 = „not at all“ to 5 = „very much“. The scores for the three dimensions are calculated by summing up the item scores for each subscale after inversion of the negative items. Subscale 'alertness – tiredness': positive items 2, 10, 17, 20; negative items: 5, 7, 13, 23. Note: Due to the character of the study, no differentiation in primary and secondary outcome variables was intended. Because at least one primary end point is required to enter study results into the database, all outcome variables are presented using the end point type primary. Baseline is defined as the last measurement before first intake of study drug.

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	117
Units: points
arithmetic mean (standard deviation)	20.76 ± 7.16	26.38 ± 8.02

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

234

Analysis specification

Pre-specified

Analysis type

other ^[66]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

5.62

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

7.2

Variability estimate

Standard deviation

Dispersion value

8.82

Notes
[66] - Within-subject change between baseline and end of treatment

Primary: Change in Multidimensional Mood State Questionnaire (MDMQ) subscale ' calmness – restlessness' between baseline and end of treatment

Top of page

End point title

Change in Multidimensional Mood State Questionnaire (MDMQ) subscale ' calmness – restlessness' between baseline and end of treatment

End point description

The Multidimensional Mood State Questionnaire is a self-rating scale to describe three dimensions of mood and wellbeing. Each subscale consists of four adjectives representing the positive and four adjectives representing the negative aspect. Each adjective is rated on a five-point scale ranging from 1 = „not at all“ to 5 = „very much“. The scores for the three dimensions are calculated by summing up the item scores for each subscale after inversion of the negative items. Subscale 'calmness – restlessness': positive items 6, 12, 15, 24; negative items: 3, 9, 19, 22 Note: Due to the character of the study, no differentiation in primary and secondary outcome variables was intended. Because at least one primary end point is required to enter study results into the database, all outcome variables are presented using the end point type primary. Baseline is defined as the last measurement before first intake of study drug.

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	117
Units: points
arithmetic mean (standard deviation)	22.26 ± 6.64	28.24 ± 7.36

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

234

Analysis specification

Pre-specified

Analysis type

other ^[67]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

5.97

Confidence interval

level

95%

sides

2-sided

lower limit

4.7

upper limit

7.2

Variability estimate

Standard deviation

Dispersion value

6.82

Notes
[67] - Within-subject change between baseline and end of treatment

Primary: Change in Multidimensional Mood State Questionnaire (MDMQ) subscale 'good mood – bad mood' between baseline and end of treatment

Top of page

End point title

Change in Multidimensional Mood State Questionnaire (MDMQ) subscale 'good mood – bad mood' between baseline and end of treatment

End point description

The Multidimensional Mood State Questionnaire is a self-rating scale to describe three dimensions of mood and wellbeing. Each subscale consists of four adjectives representing the positive and four adjectives representing the negative aspect. Each adjective is rated on a five-point scale ranging from 1 = „not at all“ to 5 = „very much“. The scores for the three dimensions are calculated by summing up the item scores for each subscale after inversion of the negative items. Subscale 'good mood – bad mood': positive items 1, 8, 14, 21; negative items: 4, 11, 16, 18. Note: Due to the character of the study, no differentiation in primary and secondary outcome variables was intended. Because at least one primary end point is required to enter study results into the database, all outcome variables are presented using the end point type primary. Baseline is defined as the last measurement before first intake of study drug.

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	117
Units: points
arithmetic mean (standard deviation)	24.08 ± 6.23	29.64 ± 6.82

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

234

Analysis specification

Pre-specified

Analysis type

other ^[68]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

5.56

Confidence interval

level

95%

sides

2-sided

lower limit

4.3

upper limit

6.9

Variability estimate

Standard deviation

Dispersion value

7.07

Notes
[68] - Within-subject change between baseline and end of treatment

Primary: Change in Clinical Global Impressions (CGI) Item 'severity of disorder' between baseline and end of treatment

Top of page

End point title

Change in Clinical Global Impressions (CGI) Item 'severity of disorder' between baseline and end of treatment

End point description

Severity of disorder: range from 0=‘not at all ill’ to 7=’extremely severe ill’ Note: Due to the character of the study, no differentiation in primary and secondary outcome variables was intended. Because at least one primary end point is required to enter study results into the database, all outcome variables are presented using the end point type primary. Baseline is defined as the last measurement before first intake of study drug.

End point type

Primary

End point timeframe

Baseline and End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117	117
Units: points
arithmetic mean (standard deviation)	3.44 ± 0.72	2.44 ± 1.14

Non-parametric analysis

Statistical analysis description

Comparison groups

Baseline v Rhodiola rosea extract (Rosalin)

Number of subjects included in analysis

234

Analysis specification

Pre-specified

Analysis type

other ^[69]

P-value

< 0.0001

Method

Wilcoxon signed-rank test

Parameter type

Mean difference (change from baseline)

Point estimate

-0.99

Confidence interval

level

95%

sides

2-sided

lower limit

-1.2

upper limit

-0.8

Variability estimate

Standard deviation

Dispersion value

1.05

Notes
[69] - Within-subject change between baseline and end of treatment

Secondary: Clinical Global Impressions (CGI) Item 'change from baseline: global improvement' at end of treatment

Top of page

End point title

Clinical Global Impressions (CGI) Item 'change from baseline: global improvement' at end of treatment

End point description

Clinical Global Impression of Change could be rated on a 7-point scale. Note: Due to the character of the study, no differentiation in primary and secondary outcome variables was intended. End point type secondary selected because only descripive statistical analysis planned for this end point.

End point type

Secondary

End point timeframe

Assessment at End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117 ^[70]	117
Units: Subjects
Very much improved	0	41
Much improved	0	26
Minimally improved	0	34
No change	0	9
Minimally worse	0	5
Not assessed	0	2

Notes
[70] - Not applicable at baseline

No statistical analyses for this end point

Secondary: Clinical Global Impressions (CGI) Item 'therapeutic effect' at end of treatment

Top of page

End point title

Clinical Global Impressions (CGI) Item 'therapeutic effect' at end of treatment

End point description

CGI-item 'therapeutic efficacy' could be rated on a 4-point scale. Note: Due to the character of the study, no differentiation in primary and secondary outcome variables was intended. End point type secondary selected because only descriptive statistical analysis plannned for this end point.

End point type

Secondary

End point timeframe

Assessment at End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117 ^[71]	117
Units: Subjects
Marked improvement	0	49
Moderate improvement	0	26
Minimal improvement	0	30
Unchanged or worse	0	8
Not assessed	0	4

Notes
[71] - Not applicable at baseline

No statistical analyses for this end point

Secondary: Clinical Global Impressions (CGI) Item 'tolerability: side effects' at end of treatment

Top of page

End point title

Clinical Global Impressions (CGI) Item 'tolerability: side effects' at end of treatment

End point description

The CGI item is asking for the relevance of adverse events to functioning in everyday-life and could be rated on a 4-point scale. Note: Due to the character of the study, no differentiation in primary and secondary outcome variables was intended. End point type secondary selected because only descriptive statistical analysis plannned for this end point.

End point type

Secondary

End point timeframe

Assessment at End of Treatment (12-week treatment period).

End point values	Baseline	Rhodiola rosea extract (Rosalin)
Number of subjects analysed	117 ^[72]	117
Units: Subjects
None	0	98
Do not signif. interfere with patients functioning	0	13
Significantly interferes with patients functioning	0	4
Not assessed	0	2

Notes
[72] - Not applicable at baseline

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

12 weeks

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

Reporting group title

Rhodiola rosea extract (Rosalin)

Reporting group description

Verum treatment

Reporting group title

No active treatment

Reporting group description

No active treatment

Serious adverse events	Rhodiola rosea extract (Rosalin)	No active treatment
Total subjects affected by serious adverse events
subjects affected / exposed	1 / 118 (0.85%)	0 / 118 (0.00%)
number of deaths (all causes)	0	0
number of deaths resulting from adverse events	0	0
Infections and infestations
Urinary tract infection
subjects affected / exposed	1 / 118 (0.85%)	0 / 118 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Rhodiola rosea extract (Rosalin)	No active treatment
Total subjects affected by non serious adverse events
subjects affected / exposed	46 / 118 (38.98%)	2 / 118 (1.69%)
Nervous system disorders
Headache
subjects affected / exposed	30 / 118 (25.42%)	1 / 118 (0.85%)
occurrences all number	36	1
Infections and infestations
Nasopharyngitis
subjects affected / exposed	12 / 118 (10.17%)	0 / 118 (0.00%)
occurrences all number	15	0
Influenza
subjects affected / exposed	12 / 118 (10.17%)	1 / 118 (0.85%)
occurrences all number	13	1

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

07 Jun 2011

Amendment No. 1: A pregnancy test for women with childbearing potential at weeks 4 and 8 was added to the trial schedule.

27 Sep 2011

Amendment No. 2: Exclusion criterion 6 was modified in order to allow the enrolment of subjects who received non-medical psychiatric treatment if it was performed in unchanged frequency for at least 6 months and remained unchanged during the course of the trial. Exclusion criterion 7 was modified in order to only allow the enrolment of subjects with intake of any prescribed psychotropic medication in sufficient dosage for a duration of minimum 4 weeks within 6 months before enrolment and no intake of any prescribed psychotropic medication within 2 weeks before enrolment resp. within 5 half-lives of the psychotropic substance

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: Multi-centre, open-label clinical trial to evaluate the efficacy and safety of Rhodiola rosea extract (Rosalin) in Subjects with Burnout Symptoms

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Change in subscale depersonalisation of the Maslach-Burnout-Inventory (MBI) between baseline and end of treatment

Primary: Change in subscale depersonalisation of the Maslach-Burnout-Inventory (MBI) between baseline and end of treatment

Primary: Change in subscale emotional exhaustion of the Maslach-Burnout-Inventory (MBI) between baseline and end of treatment

Primary: Change in subscale emotional exhaustion of the Maslach-Burnout-Inventory (MBI) between baseline and end of treatment

Primary: Change in subscale involvement of the Maslach-Burnout-Inventory (MBI) between baseline and end of treatment

Primary: Change in subscale involvement of the Maslach-Burnout-Inventory (MBI) between baseline and end of treatment

Primary: Change in subscale personal accomplishment of the Maslach-Burnout-Inventory (MBI) between baseline and end of treatment

Primary: Change in subscale personal accomplishment of the Maslach-Burnout-Inventory (MBI) between baseline and end of treatment

Primary: Change in global score intensity value of the Burnout Screening Scale (BOSS I) between baseline and end of treatment

Primary: Change in global score intensity value of the Burnout Screening Scale (BOSS I) between baseline and end of treatment

Primary: Change in global score relative width value of the Burnout Screening Scale (BOSS I) between baseline and end of treatment

Primary: Change in global score relative width value of the Burnout Screening Scale (BOSS I) between baseline and end of treatment

Primary: Change in global score total value of the Burnout Screening Scale (BOSS I) between baseline and end of treatment

Primary: Change in global score total value of the Burnout Screening Scale (BOSS I) between baseline and end of treatment

Primary: Change in intensity value of the Burnout Screening Scale (BOSS I) subscale profession between baseline and end of treatment

Primary: Change in intensity value of the Burnout Screening Scale (BOSS I) subscale profession between baseline and end of treatment

Primary: Change in relative width value of the Burnout Screening Scale (BOSS I) subscale profession between baseline and end of treatment

Primary: Change in relative width value of the Burnout Screening Scale (BOSS I) subscale profession between baseline and end of treatment

Primary: Change in total value of the Burnout Screening Scale (BOSS I) subscale profession between baseline and end of treatment

Primary: Change in total value of the Burnout Screening Scale (BOSS I) subscale profession between baseline and end of treatment

Primary: Change in intensity value of the Burnout Screening Scale (BOSS I) subscale person itself between baseline and end of treatment

Primary: Change in intensity value of the Burnout Screening Scale (BOSS I) subscale person itself between baseline and end of treatment

Primary: Change in relative width value of the Burnout Screening Scale (BOSS I) subscale person itself between baseline and end of treatment

Primary: Change in relative width value of the Burnout Screening Scale (BOSS I) subscale person itself between baseline and end of treatment

Primary: Change in total value of the Burnout Screening Scale (BOSS I) subscale person itself between baseline and end of treatment

Primary: Change in total value of the Burnout Screening Scale (BOSS I) subscale person itself between baseline and end of treatment

Primary: Change in intensity value of the Burnout Screening Scale (BOSS I) subscale family between baseline and end of treatment

Primary: Change in intensity value of the Burnout Screening Scale (BOSS I) subscale family between baseline and end of treatment

Primary: Change in relative width value of the Burnout Screening Scale (BOSS I) subscale family between baseline and end of treatment

Primary: Change in relative width value of the Burnout Screening Scale (BOSS I) subscale family between baseline and end of treatment

Primary: Change in total value of the Burnout Screening Scale (BOSS I) subscale family between baseline and end of treatment

Primary: Change in total value of the Burnout Screening Scale (BOSS I) subscale family between baseline and end of treatment

Primary: Change in intensity value of the Burnout Screening Scale (BOSS I) subscale friends between baseline and end of treatment

Primary: Change in intensity value of the Burnout Screening Scale (BOSS I) subscale friends between baseline and end of treatment

Primary: Change in relative width value of the Burnout Screening Scale (BOSS I) subscale friends between baseline and end of treatment

Primary: Change in relative width value of the Burnout Screening Scale (BOSS I) subscale friends between baseline and end of treatment

Primary: Change in total value of the Burnout Screening Scale (BOSS I) subscale friends between baseline and end of treatment

Primary: Change in total value of the Burnout Screening Scale (BOSS I) subscale friends between baseline and end of treatment

Primary: Change in global score intensity value of the Burnout Screening Scale (BOSS II) between baseline and end of treatment

Primary: Change in global score intensity value of the Burnout Screening Scale (BOSS II) between baseline and end of treatment

Primary: Change in global score relative width value of the Burnout Screening Scale (BOSS II) between baseline and end of treatment

Primary: Change in global score relative width value of the Burnout Screening Scale (BOSS II) between baseline and end of treatment

Primary: Change in global score total value of the Burnout Screening Scale (BOSS II) between baseline and end of treatment

Primary: Change in global score total value of the Burnout Screening Scale (BOSS II) between baseline and end of treatment

Primary: Change in intensity value of the Burnout Screening Scale (BOSS II) subscale physical complaints between baseline and end of treatment

Primary: Change in intensity value of the Burnout Screening Scale (BOSS II) subscale physical complaints between baseline and end of treatment

Primary: Change in relative width value of the Burnout Screening Scale (BOSS II) subscale physical complaints between baseline and end of treatment

Primary: Change in relative width value of the Burnout Screening Scale (BOSS II) subscale physical complaints between baseline and end of treatment

Primary: Change in total value of the Burnout Screening Scale (BOSS II) subscale physical complaints between baseline and end of treatment

Primary: Change in total value of the Burnout Screening Scale (BOSS II) subscale physical complaints between baseline and end of treatment

Primary: Change in intensity value of the Burnout Screening Scale (BOSS II) subscale cognitive complaints between baseline and end of treatment

Primary: Change in intensity value of the Burnout Screening Scale (BOSS II) subscale cognitive complaints between baseline and end of treatment

Primary: Change in relative width value of the Burnout Screening Scale (BOSS II) subscale cognitive complaints between baseline and end of treatment

Primary: Change in relative width value of the Burnout Screening Scale (BOSS II) subscale cognitive complaints between baseline and end of treatment

Primary: Change in total value of the Burnout Screening Scale (BOSS II) subscale cognitive complaints between baseline and end of treatment

Primary: Change in total value of the Burnout Screening Scale (BOSS II) subscale cognitive complaints between baseline and end of treatment

Primary: Change in intensity value of the Burnout Screening Scale (BOSS II) subscale emotional complaints between baseline and end of treatment

Primary: Change in intensity value of the Burnout Screening Scale (BOSS II) subscale emotional complaints between baseline and end of treatment

Primary: Change in relative width value of the Burnout Screening Scale (BOSS II) subscale emotional complaints between baseline and end of treatment

Primary: Change in relative width value of the Burnout Screening Scale (BOSS II) subscale emotional complaints between baseline and end of treatment

Primary: Change in total value of the Burnout Screening Scale (BOSS II) subscale emotional complaints between baseline and end of treatment

Primary: Change in total value of the Burnout Screening Scale (BOSS II) subscale emotional complaints between baseline and end of treatment

Primary: Change in time of the Numbers Connecting Test (ZVT) between baseline and end of treatment

Primary: Change in time of the Numbers Connecting Test (ZVT) between baseline and end of treatment

Primary: Change in subjective stress symptom anxiety assessed on a numerical analogue scale between baseline and end of treatment

Primary: Change in subjective stress symptom anxiety assessed on a numerical analogue scale between baseline and end of treatment

Primary: Change in subjective stress symptom exhaustion assessed on a numerical analogue acale between baseline and end of treatment

Primary: Change in subjective stress symptom exhaustion assessed on a numerical analogue acale between baseline and end of treatment

Primary: Change in subjective stress symptom feeling of heteronomy assessed on a numerical analogue scale between baseline and end of treatment

Primary: Change in subjective stress symptom feeling of heteronomy assessed on a numerical analogue scale between baseline and end of treatment

Clinical Trial Results:
Multi-centre, open-label clinical trial to evaluate the efficacy and safety of Rhodiola rosea extract (Rosalin) in Subjects with Burnout Symptoms