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    Summary
    EudraCT Number:2012-000436-25
    Sponsor's Protocol Code Number:RC3600
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Restarted
    Date on which this record was first entered in the EudraCT database:2012-06-20
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2012-000436-25
    A.3Full title of the trial
    Randomized, double-blinded and placebo-controlled clinical trial of the Rauvolfia-Citrus decoction in patients with type II diabetes
    Randomiseret, dobbelt-blind og placebo-kontrolleret klinisk forsøg med afkog af Rauvolfia vomitoria blade og frugter af Citrus aurantium hos patienter med type II diabetes
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical investigation of the safety and anti-diabetic efficacy of the Rauvolfia-Citrus decoction
    Klinisk undersøgelse af sikkerhed og anti-diabetisk virkning af et afkog af Rauvolfia vomitoria blade og Citrus aurantium frugter
    A.3.2Name or abbreviated title of the trial where available
    Clinical investigation of the anti-diabetic effects of the Rauvolfia-Citrus decoction
    Klinisk undersøgelse af den anti-diabetiske virkning af Rauvolfia-Citrus te
    A.4.1Sponsor's protocol code numberRC3600
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorFrederiksberg University Hospital
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportApplying for funding
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFrederiksberg University Hospital
    B.5.2Functional name of contact pointCoordinating Research Unit,
    B.5.3 Address:
    B.5.3.1Street AddressInnovaCenter, Nordre Fasanvej 57
    B.5.3.2Town/ cityFrederiksberg
    B.5.3.3Post code2000
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4538163399
    B.5.5Fax number+4538163390
    B.5.6E-mailresearch@innovacenter.dk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameRauvolfia-Citrus decoction
    D.3.2Product code RC101
    D.3.4Pharmaceutical form Oral liquid
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNUnknown
    D.3.9.1CAS number Unknown
    D.3.9.2Current sponsor codeUnknown
    D.3.9.3Other descriptive nameUnknown
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.13
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product Yes
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral liquid
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Non-insulin dependent diabetes mellitus
    Ikke-insulin krævende diabetes
    E.1.1.1Medical condition in easily understood language
    Type II diabetes
    Type II diabetes
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10012637
    E.1.2Term Diabetes with peripheral circulatory disorders
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10045248
    E.1.2Term Type II diabetes mellitus with other specified manifestations
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10045252
    E.1.2Term Type II diabetes mellitus without mention of complication
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10063624
    E.1.2Term Type II diabetes mellitus inadequate control
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10012640
    E.1.2Term Diabetes with unspecified complications
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10045242
    E.1.2Term Type II diabetes mellitus
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To validate the safety and efficacy of the RC decoction in a randomized, double blinded and placebo-controlled clinical trial in patients with Type 2 diabetes.
    At vurdere effekter og sikkerhed af RC afkog i et randomiseret, dobbelt-blind og placebo-kontrolleret kliniske forsøg med type 2-diabetes patienter.
    E.2.2Secondary objectives of the trial
    To clarify the mechanisms of action of the decoction

    To evaluate any carry-over effects of the Rauvolfia-Citrus treatment over 18 months, i.e. up to 12 months after cessation of the intervention.
    At finde ud af virkningsmekanismer af Rauvolfia-Citrus afkog

    At finde ud af om der er ”carry-over” effekter af behandling med afkoget, optil 12 måneder efter ophør af behandling.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with type II diabetes who are 40 years old or more and are taking one or more anti-diabetic treatment
    Patienter med type II diabetes, som er 40 år eller mere og er under en eller flere anti-diabetiske behandlinger
    E.4Principal exclusion criteria
    The criteria for exclusion of responders to advertisement about the study are T2D patients with:
    - clinically significant cardiovascular, renal, or liver disease (alanine aminotransferase >3 times the upper limit of normal);
    - known allergies, heart problems and uncontrolled hypertension (BP > 180/100 mmHg after 5 min rest);
    - pregnancy, breast-feeding women as well as those women with the possibility of getting pregnant (or not taking contraceptives);
    - drug abuse or a psychiatric diagnosis or who prove to be difficult to work with during the first interviews.
    Kriterierne for udelukkelse fra forsøget er hvis patienter med type II diabetes har:
    - Klinisk signifikant hjerte-, nyre- eller leversygdom (alaninaminotransferase> 3 gange højere end grænsen for normal);
    - Kendte allergier, hjerteproblemer og ukontrolleret hypertension (BT>180/100 mmHg efter 5 min hvile);
    - Gravide, ammende kvinder samt de kvinder med mulighed for at blive gravid (eller ikke tager kontraceptiva);
    - Stofmisbrug eller en psykiatrisk diagnose, eller dem som viser sig at være vanskeligt at arbejde med i de første interviews.
    E.5 End points
    E.5.1Primary end point(s)
    Normalization of HbA1c or 6 months of treatment
    Normalisering af HbA1c eller 6 måneders behandling
    E.5.1.1Timepoint(s) of evaluation of this end point
    The HbA1c value and other biochemical parameters will be measured at the clinic visits of the study participants to Frederiksberg hospital Clinical Biochemistry laboratory after 2, 4 and 6 months during the treatment phase.
    HbA1c-værdi og andre biokemiske parametre måles under klinikbesøg af forsøgsdeltagere til Klinisk Biokemisk laboratoriet på Frederiksberg Hospital, efter 2, 4 og 6 måneder i behandlingens fase.
    E.5.2Secondary end point(s)
    None. Participation will only be stopped before the 6 months treatment period is over if study participants experience adverse effects.
    Ingen. Forsøget stoppes for en enkelt deltager hvis vedkommende oplever uønsket bivirkninger.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Every day.
    Hverdag.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    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 the last subject undergoing the trial
    Forsøget afsluttes efter sidste besøg af sidste deltagere.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state250
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    We wish to monitor those who got the Rauvolfia-Citrus decoction for 6 months post treatment, to see how long they keep the positive effects on blood glucose values. Those who got placebo will be offered the 6 months treatment with the decoction.
    Vi ønsker at overvåge dem der fik Rauvolfia-Citrus afkog i 6 måneder efter behandling for at se hvor længe de holder de positive effekter på blodsukker værdier. På den anden side tilbyder vi dem der fik placebo få tilbudt de 6 måneders behandling med afkoget.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Medical Prognosis Institute
    G.4.3.4Network Country Denmark
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-06-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-05
    P. End of Trial
    P.End of Trial StatusRestarted
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