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CTRI Number  CTRI/2023/09/057720 [Registered on: 15/09/2023] Trial Registered Prospectively
Last Modified On: 04/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Other 
Public Title of Study   A randomized, double-blind, comparative, multicentric, clinical study to evaluate the safety and efficacy of Glucotas Capsules in patients with Prediabetic and Type 2 Diabetes Mellitus. 
Scientific Title of Study   A randomized, double-blind, comparative, multicentric clinical study to evaluate the safety and efficacy of GLUCOTAS Capsule in patients with prediabetes and Type 2 Diabetes Mellitus. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
ZTI/CR/001, Version: 1.0, Dated 21/04/2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mahesh Rath 
Designation  Asst. Professor and Senior Consultant in Diabetes Thyroid General Medicine and Adult Vaccination 
Affiliation  Hi-Tech Medical College and Hospital  
Address  Hi-Tech Medical College and Hospital Health Park Pandara Rasulgarh Bhubaneswar

Khordha
ORISSA
751025
India 
Phone  9040626505  
Fax    
Email  rathdrmahesh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mahesh Rath 
Designation  Asst. Professor and Senior Consultant in Diabetes Thyroid General Medicine and Adult Vaccination 
Affiliation  Hi-Tech Medical College and Hospital  
Address  Hi-Tech Medical College and Hospital Health Park Pandara Rasulgarh Bhubaneswar

Khordha
ORISSA
751025
India 
Phone  9040626505  
Fax    
Email  rathdrmahesh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Soumya Ranjan Dey 
Designation  Project Manager 
Affiliation  Indivirtus Healthcare Services Pvt. Ltd. 
Address  Indivirtus Healthcare Services Pvt. Ltd. 521-522 2nd Floor TDI City Taj Plaza Sector 118 Mohali

Chandigarh
CHANDIGARH
160059
India 
Phone  9861268508  
Fax    
Email  ctmanager@indivirtus.com  
 
Source of Monetary or Material Support  
Hi-Tech Medical College and Hospital Bhubaneswar Odisha India 
 
Primary Sponsor  
Name  Zoom Technologies Inc 
Address  100 Industrial Road Junction, Texas 76849, USA 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Chintan Patel  Aatman Hospital  5, Anveshan Row House, Opp. Umiya Mata Mandir, Bopal-Ghuma Main Road, Bopal, Ahmedabad-380058, Gujarat
Ahmadabad
GUJARAT 		 7381264432

drchintanpatel8@gmail.com 
Dr Mahesh Rath  Hi-Tech Medical College and Hospital  Health Park Pandara Rasulgarh Bhubaneswar
Khordha
ORISSA 		 9040626505

rathdrmahesh@gmail.com 
Dr Amit S Bhate  Jeevan Rekha Hospital  Dr. B R Ambedkar Road, Belagavi-590002
Belgaum
KARNATAKA 		 6370291577

dramitbhate@gmail.com 
Dr Alok Kanungo  Kanungo Institute of Diabetes Specialities  Dumduma Bhubaneswar
Khordha
ORISSA 		 9439129177

dralokkanungo@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Insitutional Ethics Committee, Hi-Tech Medical College and Hospital  Approved 
Institutional Ethics Committee Aatman Hospital  Approved 
Institutional Ethics Committee Jeevan Rekha Hospital  Approved 
KIDS Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E139||Other specified diabetes mellituswithout complications, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Comparator Agent  Each Comparator 1000 mg Capsule contains: MSM………………………………………………………………………..550 mg Glycine…………………………………………………………………….340 mg Bio-M Base………………………………………………………………110 mg  Dosage:2 Capsules TID after food for 90 days 
Intervention  GLUCOTAS Each GLUCOTAS 300 mg Capsule contains: CGA (Chlorogenic Acid) + MSM (Methylsulfonylmethane) + Bio-M + Glycine  Dosage: 2 Capsule TID after food for 90 days 
Comparator Agent  Placebo  Dosage: 2 Capsule TID after food for 90 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. All patients with duly filled in ICFs [Informed Consent Forms]
2. Treatment naive Type 2 Diabetes or Type 2 Diabetes on monotherapy
3. Hba1c level should be ≥ 5.7 and ≤ 7
4. BMI should be ≥ 25 kg/m2 and ≤ 45 kg/m2
5. Absence of any oral antidiabetic drug or any injectable antidiabetic therapy.
6. WOCBP (Women of Childbearing Potential) must be willing to use double barrier contraception for the entire study duration.
7. Patients full filling all inclusion criteria and none of exclusion criteria will be enrolled.
 
 
ExclusionCriteria 
Details  1. History of Type-1 diabetes mellitus or history of ketoacidosis.
2. Patients already on Insulin therapy.
3. Patients already on oral anti-diabetic drug therapy.
4. NYHF (New York Heart Association) Class III–IV heart failure.
5. History of coronary angioplasty, coronary stent placement, coronary bypass surgery, myocardial infarction, stroke or transient ischemic attack in the previous 3 months.
6. Pregnancy or lactating women.
7. Patients known or thought to be hypersensitivity to the investigational products.
8. Any medication or indication that might point to an increased risk, associated with study participation or Investigational Product administration or may interfere with the interpretation of study results and, in the judgment of the study personnel, would make the subject inappropriate for inclusion.
9. Participation in other clinical trials in the last three months and during study participation.
10. Patients with severe renal impairment, including those receiving dialysis.
11. Patients with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function.
12. Patient not willing to fill Informed consent form. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
• Percentage (%) change of mean HbA1c at the end of 90 days from base line.
• Percentage (%) change of mean Weight at the end of 90 days from base line
• Number of & Nature of adverse events arising out of treatment of patients with the medication & their causal relationship to study medication.
• Subjects will also be questioned about the occurrence of anticipated side effects of both treatment arm.
• Any significant changes in laboratory values of subjects compared to their baseline values.
 		 90 days 
 
Secondary Outcome  
Outcome  TimePoints 
Percentage (%) change of mean FBG & 2-hour PPBG levels from baseline to the end of treatment.  90 days 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="217" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   20/09/2023 
Date of Study Completion (India) 23/04/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
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 proposed study is a randomized, double-blind, comparative, multicentric clinical trial to evaluate the safety and efficacy of GLUCOTAS Capsule in Patients with Prediabetes and Type 2 Diabetes Mellitus. The study is proposed to be conducted at multiple sites across India to recruit 200 number of patients to meet the objective of the study. Primary outcome of this study is to evaluate percentage (%) change of mean HbA1c at the end of 90 days from baseline and secondary outcome of this study is to evaluate percentage (%) change of mean FBG and 2-hour PPBG levels from baseline to end of the treatment. 
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