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

Randomized, double-blinded and placebo-controlled clinical trial of the Rauvolfia-Citrus decoction in patients with type II diabetes - Clinical investigation of the anti-diabetic effects of the Rauvolfia-Citrus decoction

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-000436-25-DK

Enrollment

250

Registered

2012-06-20

Start date

2012-12-05

Completion date

Unknown

Last updated

2025-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-insulin dependent diabetes mellitus MedDRA version: 14.1 Level: LLT Classification code 10012637 Term: Diabetes with peripheral circulatory disorders System Organ Class: 10047065 - Vascular disorders MedDRA version: 14.1 Level: LLT Classification code 10045248 Term: Type II diabetes mellitus with other specified manifestations System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 14.1 Level: LLT Classification code 10045252 Term: Type II diabetes mellitus witho

Interventions

Product Name: Rauvolfia-Citrus decoction Product Code: RC101 Pharmaceutical Form: Oral liquid INN or Proposed INN: Unknown CAS Number: Unknown Current Sponsor code: Unknown Other descriptive name: Unk

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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 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. ;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.	—

Measure

Time frame

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 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. ;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

Measure	Time frame
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.	—

Countries

Denmark

Contacts

Public ContactCoordinating Research Unit,

Frederiksberg University Hospital

research@innovacenter.dk+4538163399

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026