| CTRI Number |
CTRI/2025/08/093385 [Registered on: 21/08/2025] Trial Registered Prospectively |
| Last Modified On: |
20/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Glycemic control with the help of Glutathione(nutritional supplement) |
|
Scientific Title of Study
|
A Double-blind, Randomized, Placebo-Controlled Study to Evaluate the Role of Glutathione-forming Multivitamins, Minerals with Amino Acid Formulation (Fourts B Tablets) in Preserving Beta-cell Function in Patients with Type 2 Diabetes mellitus. |
| Trial Acronym |
GLU-1 |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr V Mohan |
| Designation |
Chairman |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
Department of Diabetology,
Room No.:1
No.4, Conran Smith Road, Gopalapuram,
Chennai
TAMIL NADU
600086
India |
| Phone |
04443968888 |
| Fax |
04428359038 |
| Email |
drmohan@diabetes.ind.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Mohan |
| Designation |
Chairman |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
Department of Diabetology,
Room No.:1
No.4, Conran Smith Road, Gopalapuram,
Chennai
TAMIL NADU
600086
India |
| Phone |
04443968888 |
| Fax |
04428359038 |
| Email |
drmohan@diabetes.ind.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Poongothai |
| Designation |
Senior Scientist and HOD Clinical Trial |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
Department of Clinical Trials
Room No:3
No.4, Conran Smith Road, Gopalapuram
Chennai
TAMIL NADU
600086
India |
| Phone |
9840134505 |
| Fax |
|
| Email |
poongothaisubramani@gmail.com |
|
|
Source of Monetary or Material Support
|
| FOURRTS Laboratories Pvt Ltd |
|
|
Primary Sponsor
|
| Name |
Fourrts(india) Laboratories Pvt. Ltd |
| Address |
Thoraipakkam Chennai Tamil Nadu 600097 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Subramani Poongothai |
Madras Diabetes Research Foundation |
Department of clinical Trials
Room No:3,
4 conran Smith Road Gopalapuram
Chennai
TAMIL NADU |
09840134505
poongothaisubramani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Of Madras Diabetes Research Foundation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fourts B Tablet(Glutathione) |
Fourts B Tablet(Glutathione) - Contains glutathione forming amino acids (acetyl cysteine, glycine and glutamic acid). |
| Comparator Agent |
Placebo |
Vitamins |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult patients between 18-70 years of age of both genders
2.Subjects with type 2 diabetes mellitus
3.Subjects willing to give written informed consent
4.HbA1c range 7-11%
5.one or two oral antidiabetic medication
|
|
| ExclusionCriteria |
| Details |
1.Patients with type 1 diabetes mellitus
2.Pregnant or lactating women
3.Patients with severe chronic kidney disease
4.Patients with a history of myocardial infarction, coronary artery bypass graft surgery, or percutaneous transluminal coronary angioplasty/stent within 3 months of study start
5.Patients having suffered cerebrovascular event within 3 months of start of study
6.Patients with cardiac failure categorized as Class III or IV as per New York Heart Association Functional Classification
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in C-peptide levels from baseline to study end between the intervention and
control arms
|
3 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in HOMA B & HOMA IR levels
Measure Glutathione levels |
O month & 3 month |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/09/2025 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Standard therapeutic strategies for T2DM focus on glycemic control through lifestyle modification and oral antidiabetic drugs.Emerging evidence suggests that certain nutritional supplements may offer ancillary benefits by modulating metabolic pathways, reducing inflammation, and supporting cellular function. Fourrts B tablets, a nutritional supplement containing essential vitamins such as B complex, minerals, and antioxidants, may improve insulin sensitivity and preserve beta cell function when used alongside standard OAD therapy. This study evaluates whether the addition of Fourrts B tablets to conventional OAD regimens can provide superior outcomes in reducing insulin resistance and improving beta-cell function, thereby offering a more holistic and sustainable approach to T2DM management.This could be a cost-effective treatment for improving clinical outcomes and slowing progression in those patients who are prone to long term complications of diabetes. |