Clinical investigation of the safety and anti-diabetic efficacy of the Rauvolfia-Citrus decoctio

Phase 1

• Conditions: on-insulin dependent diabetes mellitus; MedDRA version: 14.1Level: LLTClassification code 10012637Term: Diabetes with peripheral circulatory disordersSystem Organ Class: 10047065 - Vascular disorders; MedDRA version: 14.1Level: LLTClassification code 10045248Term: Type II diabetes mellitus with other specified manifestationsSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 14.1Level: LLTClassification code 10045252Term: Type II diabetes mellitus without mention of complicationSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 14.1Level: LLTClassification code 10063624Term: Type II diabetes mellitus inadequate controlSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 14.1Level: LLTClassification code 10012640Term: Diabetes with unspecified complicationsSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 14.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2012-000436-25-DK
• Lead Sponsor: Frederiksberg University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-20
• Last Update Posted: 20 August 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Patients with type II diabetes who are 40 years old or more and are taking one or more anti-diabetic treatment
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: To clarify the mechanisms of action of the decoction <br><br>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.<br>;Primary end point(s): Normalization of HbA1c or 6 months of treatment;Timepoint(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.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): None. Participation will only be stopped before the 6 months treatment period is over if study participants experience adverse effects.;Timepoint(s) of evaluation of this end point: Every day.