| CTRI Number |
CTRI/2024/07/071682 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
06/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to assess the effect of Glucocil® on metabolic health in individuals with prediabetes and Type 2 Diabetes Mellitus |
|
Scientific Title of Study
|
A randomized, double-blind, placebo-controlled study to assess the effect of Glucocil® on metabolic health in individuals with prediabetes and Type 2 Diabetes Mellitus |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NH/231201/GC/DM Version No:1.0 DATE: June 17th, 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shalini Srivastava |
| Designation |
Director – Clinical Development & Strategy |
| Affiliation |
Vedic Lifesciences Pvt. Ltd. |
| Address |
Vedic Lifesciences Pvt Ltd 118 B Morya House off New Link Road
Andheri West Mumbai Mumbai (Suburban) MAHARASHTRA 400053
Mumbai
MAHARASHTRA
400053
India |
| Phone |
7738418890 |
| Fax |
|
| Email |
shalini.s@vediclifesciences.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shalini Srivastava |
| Designation |
Director – Clinical Development & Strategy |
| Affiliation |
Vedic Lifesciences Pvt. Ltd. |
| Address |
Vedic Lifesciences Pvt Ltd 118 B Morya House off New Link Road
Andheri West Mumbai Mumbai (Suburban) MAHARASHTRA 400053
Mumbai
MAHARASHTRA
400053
India |
| Phone |
7738418890 |
| Fax |
|
| Email |
shalini.s@vediclifesciences.com |
|
Details of Contact Person
Public Query
|
| Name |
Lalit Pawaskar |
| Designation |
Project Lead |
| Affiliation |
Vedic Lifesciences Pvt. Ltd. |
| Address |
Vedic Lifesciences Pvt Ltd 118 B Morya House off New Link Road
Andheri West Mumbai Mumbai (Suburban) MAHARASHTRA 400053
Mumbai
MAHARASHTRA
400053
India |
| Phone |
7738418890 |
| Fax |
|
| Email |
lalit.p@vediclifesciences.com |
|
|
Source of Monetary or Material Support
|
| Vedic Lifesciences Pvt. Ltd. 118-B, Morya House, off New Link Road, Andheri West Mumbai
–400053, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Vedic Lifesciences Pvt. Ltd |
| Address |
Vedic Lifesciences Pvt. Ltd. 118-B, Morya House, off New Link Road, Andheri West Mumbai –400053, Maharashtra, India |
| Type of Sponsor |
Contract research organization |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Govid Rankawat |
Dr.Govinds Clinic, |
Dr.Govinds Clinic, 267/24, Sec-26, Pratap nagar, Jaipur, 302033
Jaipur
RAJASTHAN |
7891368525
drgovind.rankawat@gmail.com |
| Dr Dilip Chaurasiya |
Arihant Hospital |
Opd No.01 ,Arihant Hospital, Akhari, Department -General Medicines Bypass,Varanasi-UP-221011
Varanasi
UTTAR PRADESH |
7292022991
dilipchaurasiya250@gmail.com |
| Dr Nikhil More |
Shourya clinic |
Shop no 2, Phoenix plaza, marvel Ideal Spacio, Jagdamba Bhawan Marg, Shree Siddhivinayak Meera, Undri, Pune, Maharashtra 411060.
Mumbai
MAHARASHTRA |
8446512457
nikhilmore8750@gmail.com |
| Dr Hemant Ingole |
Shri balaji Multispeciality hospital |
OPD No:02 ,Shri balaji Multispeciality hospital, Trident A building, Raut chowk, Mohan palms road, Shirgaon,Badalapur, Maharashtra-421503
Thane
MAHARASHTRA |
8600848920
hemantingole11@gmail.com |
| Dr Gaurav Singh |
Upendra Medicare |
Upendra Medicare 4/50, D-4-A,Mahabeer mandir,Orderly bajar,tajpur,Varanasi-221001
Varanasi
UTTAR PRADESH |
9555112643
drgauravsingh371@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Altezza Institutional Ethics Committe |
Approved |
| Altezza Institutional ethics committee |
Approved |
| Central Independent Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee JNU Institute for Medical Services & Research Centre |
Approved |
| Supreme Independent Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Prediabetes |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Active (Combination of Vitamin B1, B6, B12, D3, Chromium Picolinate, Proprietary Mulberry Leaf Extract, Cinnamon Bark Powder, Gymnema Sylvestre Extract, Insulina (Cissus Sicyoides) Leaf Extract, Alpha Lipoic Acid, Phellodendron Bark Extract (Berberine HCL), Cissus Quadrangularis Extract, Banaba Leaf Extract, & Fish Oil) |
Two soft gels to be taken with breakfast and two soft gels are to be taken with dinner for 90 days |
| Comparator Agent |
Placebo(Soyabean oil) |
Two soft gels to be taken with breakfast and two soft gels are to be taken with dinner for 90 days |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Males and females of age more than equal to 30 years and less than equal to 70 years.
2.Body mass index within 30 kg/m2 and 35 kg/m2 (both values included) with waist circumference above 40 inches (men) or 35 inches (women).
3.Cohort 1 (Only for prediabetes individuals)- Individuals diagnosed with prediabetes with OGTT (140 mg/dL to 199 mg/dL); HbA1c (5.7% to 6.9%) and fasting blood glucose level (between 100 mg/dL to 125 mg/dL).
4.Cohort 2 (T2DM)- Individuals newly diagnosed with Type 2 diabetes mellitus with HbA1c between 7% and 9% (both values included) and fasting blood glucose level in between 126 to 180 mg/dL
5.Triglycerides between 150 mg/dL and 299 mg/dL (both values inclusive) and/or Low-Density Lipoprotein (LDL) in between 130 mg/dL and 189 mg/dL (both values inclusive).
6. Individuals having non-vegetarian diet for at least 2 days a week.
7. Non-smoker.
8. Individuals who are willing to not change their physical activity levels throughout the study period.
9. Individuals willing to complete all study-related questionnaires and to complete all clinical study visits.
10. Individuals ready to give voluntary, written informed consent to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1. Individuals who are vegetarians
2. Individuals with Type 1 diabetes mellitus
3. Individuals with Type 2 diabetes mellitus on medication
4. Individuals with any other endocrine disorder
5. Individuals currently on diuretics or thyroid supplements.
6. Individuals on lipid-lowering therapies
7. Individuals with uncontrolled hypertenstion as assessed by systolic over diastolic blood pressure (Greater than equal to 140/90mmHg)
8. Individuals currently on antihypertensive medication
9. Individuals with cardiac arrhythmia, impaired hepatic or renal function
10. Individuals having heart failure, coronary artery disease, hyperthyroidism, hypothyroidism, cancer or mental disease or any other serious disease requiring active treatment
11. History of malignancy or stroke
12. Chronic alcoholism History and/or current cases of chronic alcohol consumption or heavy drinkers as defined by
a) For men, consuming more than 4 drinks on any day or more than 14 drinks/week
b) For women, consuming more than 3 drinks on any day or more than 7 drinks/week
13. Individuals taking concomitant medication known to alter blood sugar
14. Individuals having treatment with any other herbal or any other supplements
15. Any condition or abnormality that would compromise the safety of the individuals or the quality of the study data.
16. Use of another investigational product within 3 months of the screening visit
17. Females who are lactating, pregnant or planning to be pregnant or taking any oral contraceptives. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Cohort 2- (Type 2 diabetes mellitus (T2DM))
To assess the effect of Investigational Product (IP) on blood sugar as assessed by Glycated haemoglobin (HbA1c) in individuals with Type 2 diabetes mellitus (T2DM). |
Screening visit (The same value will be considered for baseline) and Day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Cohort 1- ( Pre-diabetes)
To assess the effect of Investigational Product (IP) on blood sugar in Pre-diabetes as assessed by 2-hour plasma glucose level by Oral Glucose Tolerance Test (OGTT) |
Screening visit (The same value will be considered for baseline) and Day 90. |
Cohort 1- ( Pre-diabetes)
To assess the effect of Investigational Product (IP) on blood sugar as assessed by Glucose metabolism as assessed by change in the HbA1c |
Screening visit (The same value will be considered for baseline) and Day 90. |
Cohort 1 (Prediabetes) & Cohort 2 (T2DM):
To assess the effect of IP on following compared to baseline and placebo:
1.Pancreatic efficiency as assessed by the change in the fasting insulin
2. Percentage change in body weight by weighing scale
3.Change in central obesity as assessed by the change in the anthropometric index of waist-to-height ratio
4. Change in the Fasting Blood Glucose (FBG)
5. Change in Quality of life as assessed by SF- 6Dv2TM Health Survey
6.Change in the Eating behavior as assessed by Three factor eating questionnaire – Revised 18 (TFEQ-R18) |
Day 0, Day 30, Day 60, Day 90 |
To assess the effect of Investigational product (IP) on:Lipid profile [total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides]
|
Screening visit (The same value will be considered for baseline) and Day 90. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/08/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="25" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The present study is a randomized, double-blind, placebo-controlled study. 125 individuals will be screened and considering a screening failure rate of 20%, approximately 100 individuals will be randomized in a ratio of 1:1 to receive either IP or placebo and will be assigned a unique randomization code. Each group will have at least 80 (40 per arm) evaluable participants after accounting for a dropout/withdrawal rate of 20%. The intervention duration for all the study participants is 90 days. |