| CTRI Number |
CTRI/2025/12/099686 [Registered on: 22/12/2025] Trial Registered Prospectively |
| Last Modified On: |
22/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Gymnema Extract for Blood Sugar Control in Pre-Diabetic Adults |
|
Scientific Title of Study
|
A 12-week randomized, double-blind, placebo-controlled human clinical trial for the evaluation of safety and efficacy of Gymnema extract(Melitwocut®) in the management of Blood Sugar Levels in pre-diabetic individuals. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| RRS/CL/GYM/BG/2025 Version : 1.0 Date: 03rd Jul 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prabhakar K |
| Designation |
Principal Investigator |
| Affiliation |
R L Jalappa Hospital & Research Centre, Sri Devaraj Urs Medical College |
| Address |
Department of General medicine
R L Jalappa Hospital & Research Centre, Sri Devaraj Urs Medical College,Tamaka, Kolar, Karnataka 563101
Kolar
KARNATAKA
563101
India |
| Phone |
9448048308 |
| Fax |
|
| Email |
drprabhakar@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Godavarthi |
| Designation |
CEO |
| Affiliation |
Radiant Research Services Pvt Ltd |
| Address |
Radiant Research Services Pvt Ltd. Plot No: 99/A, 8th Main Road, III Phase, Peenya Industrial Area, Bengaluru- 560058,Karnataka, India
Bangalore
KARNATAKA
560058
India |
| Phone |
09880999297 |
| Fax |
|
| Email |
surya.ashok@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok Godavarthi |
| Designation |
CEO |
| Affiliation |
Radiant Research Services Pvt Ltd |
| Address |
Radiant Research Services Pvt Ltd. Plot No: 99/A, 8th Main Road, III Phase, Peenya Industrial Area, Bengaluru- 560058,Karnataka, India
Bangalore
KARNATAKA
560058
India |
| Phone |
09880999297 |
| Fax |
|
| Email |
surya.ashok@gmail.com |
|
|
Source of Monetary or Material Support
|
| CELL GREEN BIOLAB Co., Ltd. 6th floor M81, 602,Yeongdong-daero, Gangnam-gu, Seoul-06130,Republic of Korea. |
|
|
Primary Sponsor
|
| Name |
CELL GREEN BIOLAB Co Ltd |
| Address |
6th floor M81, 602,Yeongdong-daero, Gangnam-gu, Seoul- 06130, Republic of Korea. |
| Type of Sponsor |
Other [Nutraceutical supplement company] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prabhakar K |
R L Jalappa Hospital & Research Centre, Sri Devaraj Urs Medical College |
Department of General medicine R L Jalappa Hospital & Research Centre, Sri Devaraj Urs Medical College, Tamaka, Kolar, Karnataka 563101
Kolar
KARNATAKA |
09448048308
drprabhakar@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Central Ethics Committee, Sri Devaraj Urs Academy of Higher Education & Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E139||Other specified diabetes mellituswithout complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gymnema extract (Melitwocut®) |
Dose :500mg, Doasge form: Capusle, 1 capsule 15 minutes before breakfast and dinner , Total Duration 84days |
| Comparator Agent |
Placebo |
Dose :500mg, Doasge form: Capusle, 1 capsule 15 minutes before breakfast and dinner , Total Duration 84days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Both male and female subjects aged between 20 and 65 years (both inclusive).
2. Individuals those in the prediabetic range (fasting blood glucose 100 to 125 mg per dL and
postprandial blood glucose 140 to 199 mg per dL) who are not taking medication.
3. Subjects who are willing to provide informed consent and participate in the study. |
|
| ExclusionCriteria |
| Details |
1. Individuals with drug dependence.
2. Individuals who have been administered hypoglycemic agents within the past 3 months.
3. Individuals with abnormal thyroid function.
4. Individuals with gastrointestinal dysfunction.
5. Individuals with congenital deficiency of sugar-degrading enzymes.
6. Individuals with lipid metabolism disorders and those with acute or chronic inflammation
7. Individuals with cardiovascular diseases such as heart failure, myocardial infarction or stroke.
8. Pregnant or lactating women or those planning to become pregnant.
9. Individuals with allergies or adverse reactions to the investigational product.
10. Individuals consuming alcohol males greater than or equal to 40 g per day females greater than or equal to 20 g per day (according to WHO daily alcohol intake standards)
11. Heavy smokers- greater than or equal to 20 cigarettes per day
12. Individuals who used any pharmacological treatment, medicinal herb, or supplement during the previous 3 months which has effect on study parameters will be excluded.
13. Individuals who have participated in another clinical trial within the past 3 months.
14. Individuals deemed unsuitable for this study by the investigator. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Blood Sugar Level Tests-Fasting blood sugar (FBS) & Post prandial blood sugar (PPBS)
2. Glycated hemoglobin (HbA1c)
3. Oral Glucose Tolerance Test (OGTT) |
Screening visit, Day 42,Day 84
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.HOMA-IR score (Screening visit, Day 42,Day 84)
2.Serum Insulin levels
3.Serum Adiponectin levels
4.C-Peptide test
5.Safety assessments-Biochemistry, Hematology (CBC) LFT & RFT, Lipid profile(Screening visit and Day 84) |
Day0,Day 42,Day 84 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Diabetes mellitus (DM) is a metabolic disease, involving inappropriately elevated blood glucose levels. In India, there are estimated 77
million people above the age of 18 years are suffering from diabetes (type 2) and nearly 25
million are pre-diabetics (at a higher risk of developing diabetes in near future). More than half
of the people are unaware of their diabetic status which leads to health complications if not
detected and treated early. Gymnema sylvestre has long been valued in Ayurvedic medicine for its role in metabolic health,
particularly in supporting blood sugar regulation. The extract, derived from its leaves, is rich in
bioactive compounds, primarily gymnemic acids, which have been extensively studied for their
ability to aid in glycaemic control and insulin function. To ensure the potency and efficacy of its
active components, Gymnema extract is typically obtained through aqueous or ethanol-based
extraction methods, preserving its beneficial properties. It is commercially available in various
formulations, including powder, capsules, and liquid extracts, with many preparations
standardized for gymnemic acid content to maintain consistency in therapeutic applications. |