| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Common Cold (nasopharyngitis), Upper Respiratory Tract Infection |
|
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 8.0 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10028810 |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| To assess the effectiveness of a combination of natural plant extracts on the severity of the common cold relative to a placebo control when used within 36 hours of the first signs of the cold. |
|
| E.2.2 | Secondary objectives of the trial |
| To assess the effectiveness of an active control (ibuprofen plus chlorphenamine maleate) versus the placebo control. |
|
| E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
| E.3 | Principal inclusion criteria |
a) Subject is male or female aged at least 18 years, and in good health;
b) Female subjects of child bearing potential have a negative urine pregnancy test and are currently using an acceptable method of birth control, at the discretion of the Investigator;
c) Subject thinks that he/she is coming down with a cold, with the first signs of the cold occurring no more than 36 hours prior to Visit 1;
d) Subject has a symptom score of 1 or greater for either sore/scratchy throat, runny nose or stuffy/congested nose at Visit 1;
e) Subject has a value of 7 or less for the sum of the severity scores across the symptoms assessed at Visit 1 (sore/scratchy throat, runny nose, stuffy/congested nose, cough, tired/run down feeling, chilliness, sneezing, and headache);
f) Subject has read, signed, dated, and received a copy of the Informed Consent prior to initiation of the study procedures;
g) Subject agrees to avoid alcohol starting at enrollment (Visit 1) and continuing through Day 7;
h) Subject agrees to consume 3 or less cups of coffee or other caffeinated beverages per day starting at enrollment (Visit 1) and continuing through Day 7;
i) Subject agrees to refrain from taking any products including vitamins, dietary supplements, and homeopathic preparations intended to prevent, intervene in, or treat cough/colds/flu starting at enrollment (Visit 1) and continuing through Day 7 (e.g., those containing vitamin C, zinc, Echinacea); use of a daily multivitamin is allowed;
j) Subject agrees to refrain from taking any products including vitamins, dietary supplements, and homeopathic preparations that are intended for sinus/allergy/pain relief starting at enrollment (Visit 1) and continuing through Day 7 (e.g., those containing antihistamines, anticholinergics, decongestants, analgesics); use of low dose aspirin (81-100 mg/day) for cardiac prophylaxis and a daily multivitamin are allowed;
|
|
| E.4 | Principal exclusion criteria |
a) Have a known hypersensitivity or are allergic to any component of the test products (see section 3.4.3);
b) Are breast-feeding, pregnant, or attempting to become pregnant;
c) Have had nasal or sinus surgery in the last 2 years or have a clinically significant abnormality of the upper respiratory tract (e.g., chronic nose bleeds, nasal polyp, irreversible nasal mucosal hypertrophy, severe nasal septal deviation);
d) Have had a malignancy within the last two years;
e) Have or have ever had a respiratory disease (e.g., chronic rhinitis, sinusitis, asthma or reactive airway disease, chronic bronchitis, pneumonia, persistent or chronic cough, emphysema, breathing problems, excessive phlegm or mucus), cardiovascular disease (e.g., myocardial infarction, hypertension), gastrointestinal disease (e.g., hyperacidity, gastrointestinal ulcer, obstruction of bile passages, gall bladder obstruction, gall stones), endocrine disease (e.g., diabetes, thyroid disease, including an overactive thyroid gland), ophthalmic disease (e.g., glaucoma), neurological disease (e.g., epilepsy), urological disease/condition (e.g., an enlarged prostate gland), or hepatic, renal, hematological, or immunological disease;
f) Experience frequent headaches/migraines (3 or more times per week);
g) Are currently taking medicines containing phenytoin, heparins, antiplatelet agents, thrombolytic agents, anticoagulants, or medicines to treat anxiety or sleep disorders;
h) Have taken MAOI (monoamine oxidase inhibitor) drugs within 14 days of Visit 1;
i) Have taken any products including vitamins, dietary supplements, and homeopathic preparations intended to prevent, intervene in, or treat cough/colds/flu within 24 hours of Visit 1 (e.g., those containing vitamin C, zinc, Echinacea); use of a daily multivitamin is allowed;
j) Have taken any products including vitamins, dietary supplements, and homeopathic preparations that are intended for sinus/allergy/pain relief within 24 hours of Visit 1 (e.g., those containing antihistamines, anticholinergics, decongestants, analgesics); use of low dose aspirin (81-100 mg/day) for cardiac prophylaxis and a daily multivitamin are allowed;
k) Are currently experiencing symptoms of respiratory or seasonal allergy;
l) Have a temperature greater than 38.3° C at Visit 1;
m) Have smoked cigarettes for more than 20 pack/day years (number of pack/day years is number of years smoked times average number of packs smoked per day);
n) Have received any investigational drug or participated in a clinical trial within 4 weeks of Visit 1 or are currently enrolled in another investigational study;
o) Are related to any study personnel;
p) Have a condition or have taken / are currently taking a medication that the Investigator and/or designee believes could jeopardize the safety of the subject, interfere with the evaluation of the study, or confound the interpretation of the study results, or otherwise be considered unsuitable for entry into the study by the Investigator.
|
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
The primary comparison of interest for the study will be that of patients taking Kan Jang (PR1) and Curcumin (PR4) concomitantly versus placebo. The secondary comparison will be that of patients taking Ibuprofen (PR2) and Chlorphenamine (PR3) concomitantly. In both cases the primary end point will be the patient assessment of severity of the cold, which will be a summation of the following severity scores;
sore/scratchy throat severity,
runny nose severity,
stuffy/congested nose severity,
cough severity,
Tired / Run-down Feeling severity
Difficulty sleeping severity.
|
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | Information not present in EudraCT |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | Information not present in EudraCT |
| E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
| E.7.1.3 | Other | Information not present in EudraCT |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | No |
| E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
| E.8.4 | The trial involves multiple sites in the Member State concerned | No |
| E.8.5 | The trial involves multiple Member States | No |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
| Last visit of last subject undergoing the trial. |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 0 |
| E.8.9.1 | In the Member State concerned months | 6 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial years | 0 |
| E.8.9.2 | In all countries concerned by the trial months | 6 |
Print
