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CTRI Number  CTRI/2024/09/073348 [Registered on: 04/09/2024] Trial Registered Prospectively
Last Modified On: 22/05/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Probiotic 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To check the effect of probiotics in type 2 diabetic patient 
Scientific Title of Study   A randomized double blinded placebo controlled comparative clinical study to evaluate the safety and efficacy of probiotics in the management of type 2 diabetic patients. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Protocol No: PROBIOTICS/09/24 Version: 1.0  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr M Sakthi Balan MD  
Designation  Consultant, Physician  
Affiliation  Ki3 Private Limited 
Address  Room 2, Thirumalai Medical Centre, No 408, Cuddalore Road Nainarmanadapam, Puducherry

Pondicherry
PONDICHERRY
605004
India 
Phone  9443627722  
Fax    
Email  saheerose@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr M Sakthi Balan MD  
Designation  Consultant, Physician  
Affiliation  Ki3 Private Limited 
Address  Room 2, Thirumalai Medical Centre, No 408, Cuddalore Road Nainarmanadapam, Puducherry

Pondicherry
PONDICHERRY
605004
India 
Phone  9443627722  
Fax    
Email  saheerose@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Gayathri Sivakumar 
Designation  Ditrector 
Affiliation  Ki3 Private Limited 
Address  Room No 1, Ki3 Private Limited, Regus Centre Level 2 Altius Block, No 1, SIDCO Industrial Estate, Chennai

Chennai
TAMIL NADU
600044
India 
Phone  9003109416  
Fax    
Email  drgayathri@ki3services.com  
 
Source of Monetary or Material Support  
SA Pharmachem Pvt. Ltd., India. 
 
Primary Sponsor  
Name  SA Pharmachem Pvt. Ltd., India. 
Address  220, Udyog Bhavan, Sonawala Road, Goregaon East, Mumbai – 400063 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Vinay Pandit   All India Institute of Medical Science, Raipur  Professor &Head Dept Of General D Block Ground Floor Medicine OPD, AIIMS Raipur Tatibandh Ge Road Raipur(C.G) 492099
Raipur
CHHATTISGARH 		 9844175598

vinayrpandit@gmail.com 
Dr M Sakthi Balan   DK Elite Health Care Center  Room no. 1,First Floor, No.370, Cuddalore main Road,Nainarmandapam, Puducherry
Pondicherry
PONDICHERRY 		 9443627722

saheerose@gmail.com 
Dr M Venkatram MBBS MD  East Coast Hospitals  Room 1, General Medicine, 1, Paris Nager, Moolakulam, Puducherry-605010
Pondicherry
PONDICHERRY 		 9042846842

labservices@eastcoasthospitals.com 
Dr Anandakumar  Oxymed Hospital and Research Institute  Consultation Room No.1, Consultant Diabetologist, No 14/1 2nd street, 3rd main road, Nandhanam, Chennai 600035
Chennai
TAMIL NADU 		 9840036723

Srmc91@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
AIIMS Raipur Institutional Ethics Committee  Submittted/Under Review 
Ethique De La Nature Association  Approved 
Ethique De La Nature Association  Approved 
Oxymed Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
Comparator Agent  Glimepiride 1/2 mg + Metformin 500 mg + Placebo  One capsule/tablet twice daily orally for 90 days 
Intervention  Glimepiride 1/2 mg + Metformin 500 mg + Probiotics  One capsule/tablet twice daily orally for 90 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Willing and able to provide written informed consent prior to performing study procedures.
2. Type II diabetic patients between the age of 18-65 years.
3. Males or females; females must be non-pregnant / non-lactating and practicing adequate
birth control measures if not menopausal.
4. Participants with HbA1c 6.5 - 10.
5. Patient should not have participated in any other clinical trial during the past 3 months. 
 
ExclusionCriteria 
Details  1. Type 1 diabetes mellitus and pre diabetics.
2. Concomitant gastrointestinal disorders (i.e., irritable bowel
syndrome, inflammatory bowel disease and coeliac disease)
3. Recent use (within the previous 4 weeks) of antibiotics and
dietary supplements (fish oil, probiotics, prebiotics,
multivitamins, minerals, nutraceuticals and herbal preparations)
4. K/C/o cardiovascular or renal complications.
5. Patients who are on immunomodulatory or immunosuppressants
for any other illness.
6. History of allergy to probiotics.
7. History of drug or alcohol abuse. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Fasting and post prandial blood sugar levels. (Time points: Day
0, Day 30, Day 60 and Day 90)
2. HbA1c levels (Time points: Day 0 and Day 90)
3. Overall global status of improvement and quality of life (Time
points: Day 0 and Day 90)
4. Change in the anthropometrics and blood pressure measurements
from baseline to post study (Time points: Day 0 and Day 90)
5. Change in lipid profile from baseline to post study (Time points:
Day 0 and Day 90) 		 Day 0, Day 30, Day 60 and Day 90 
 
Secondary Outcome  
Outcome  TimePoints 
● Each patient will undergo a complete physical examination, blood
sugar level assessment before enrolment in the study.
● Other blood parameters like CBC, RFT, LFT and lipid profile will
be done on Day 0 and Day 90 for safety purpose.
● ADR monitoring 		 Day 0 and Day 90 
 
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   Phase 3 
Date of First Enrollment (India)   06/09/2024 
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 Yet Recruiting 
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   The subjects who fulfilled the inclusion and exclusion criteria will be enrolled in the study. 100 participants will be randomized into two groups. Dosing will be done twice daily orally for 90 days. Subjects will be asked to visit facility for their follow up on day 30, day 60 and day 90 and any other additional visits if needed.

Primary Outcome
1. Fasting and post prandial blood sugar levels. (Time points: Day
0, Day 30, Day 60 and Day 90)
2. HbA1c levels (Time points: Day 0 and Day 90)
3. Overall global status of improvement and quality of life (Time
points: Day 0 and Day 90)
4. Change in the anthropometrics and blood pressure measurements
from baseline to post study (Time points: Day 0 and Day 90)
5. Change in lipid profile from baseline to post study (Time points:
Day 0 and Day 90)
 
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