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CTRI Number  CTRI/2024/03/063627 [Registered on: 05/03/2024] Trial Registered Prospectively
Last Modified On: 02/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A Clinical Study to Evaluate the effect of F-Biotic in Type 2 Diabetes Mellitus Subjects.  
Scientific Title of Study   A Randomized, Double-Blind, Placebo-Controlled, Clinical Study to Evaluate the Efficacy of F-Bioticâ„¢ in Type 2 Diabetes Mellitus Subjects as an Adjuvant to Stable Metformin Therapy.  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
LCBS-AR-124 Version No :1.0 Date 21 October 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Harshith C S 
Designation  Assistant Professor, Department of General Medicine 
Affiliation  BGS Global Institute of Medical Sciences 
Address  Department of General Medicine,No.67, BGS Health and Education City, Uttarahalli Road, Kengeri

Bangalore
KARNATAKA
560060
India 
Phone  9741073960  
Fax    
Email  drharshithcs.research@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Jestin V Thomas 
Designation  Director 
Affiliation  Leads Clinical Research and Bio Services Pvt. Ltd 
Address  Department of Clinical Research, No.9, Mythri Legacy, Kalyan Nagar, Chelekere Main Road

Bangalore
KARNATAKA
560043
India 
Phone  9845125293  
Fax    
Email  jestin.leadsclinbio@gmail.com  
 
Details of Contact Person
Public Query  
Name  Jestin V Thomas 
Designation  Director 
Affiliation  Leads Clinical Research and Bio Services Pvt. Ltd 
Address  Department of Clinical Research, No.9, Mythri Legacy, Kalyan Nagar, Chelekere Main Road

Bangalore
KARNATAKA
560043
India 
Phone  9845125293  
Fax    
Email  jestin.leadsclinbio@gmail.com  
 
Source of Monetary or Material Support  
Arishina Life Sciences Pvt. Ltd. Second Floor, 17/560-C8 Mini Mall, Athani Nedumbassery, Ernakulam - 683585 Kerala, India 
 
Primary Sponsor  
Name  Arishina Life Sciences Pvt. Ltd.  
Address  Second Floor, 17-560-C8 Mini Mall, Athani Nedumbassery, Ernakulam - 683585 Kerala, India 
Type of Sponsor  Other [Manufacturer of natural plant based food ingredients and Nutraceutical ingredients] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Harshith C S  BGS Global Institute of Medical Sciences  Department of General medicine, 5th Floor, Research Ward, No.67,BGS Health and Education City, Uttarahalli Road,Kengeri
Bangalore
KARNATAKA 		 9741073960

drharshithcs.research@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, BGS Global Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E11||Type 2 diabetes mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  F-Bioticâ„¢   Oral Administration of a Single sachet of F-Bioticâ„¢ once a day for 12 weeks  
Comparator Agent  Placebo  Oral Administration of a single sachet of placebo once a day for 12 weeks 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Subjects diagnosed with Type 2 diabetes mellitus on stable metformin monotherapy for 8 weeks prior to the screening with:
o Glycated hemoglobin (HbA1c) between greater than or equal to 6.6 and less than or equal to 9%
o Fasting blood sugar greater than or equal to 126 mg per dl
o BMI of 23-32 kg per meter square

2. Females of childbearing age, agree to use approved birth control methods during the study, and
have negative urine pregnancy test at screening.

3. Subject willing to adhere with their routine diet, physical activity, and general lifestyle
throughout the study.

4. Must be willing and able to give informed consent and comply with the study procedures. 
 
ExclusionCriteria 
Details  1. Subjects diagnosed with Type 1 diabetes mellitus
2. Subjects currently on any medications or supplements other than metformin known to influence blood glucose concentration
3. Subjects with following levels at Screening visit
o Fasting blood triglycerides greather than 400 mg per dL
o Low density lipoprotein (LDL) greater than 190 mg per dL
o HbA1c greater than 9%
4. Subjects with history of
o Uncontrolled or serious medical illness including renal, liver disease, hypertension.
o Diabetes ketoacidosis
o Cardiac disease or neurological problems
o Auto-immune disease (rheumatoid arthritis, lupus, type 1 diabetes)
o Gastrointestinal tract bleeding or peptic ulcer disease
o Psychiatric disorders or Severe neurological diseases or seizures
5. Subjects who maybe allergic to any of the natural constituents of the Investigational Product
6. Known HIV or Hepatitis B positive or any other immuno-compromised state
7. Pregnant and lactating women
8. Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this
study
9. Any additional condition(s) that in the Investigators opinion that may interfere with subject treatment, assessment or compliance
with the protocol and would warrant exclusion from the study or prevent the subject from completing the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Mean change in Fasting blood sugar levels

 		 Baseline, Day 42, Day 84 
 
Secondary Outcome  
Outcome  TimePoints 
Mean change in biochemical parameters and biomarkers   Baseline, Day 42, Day 84 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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/ Phase 4 
Date of First Enrollment (India)   11/03/2024 
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="5"
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  
This is a randomized (1:1), double-blind, two-arm, placebo-controlled, parallel group, clinical study. Type 2 Diabetes Mellitus (T2DM) subjects on stable metformin monotherapy medication for at least 8 weeks and meeting all inclusion and exclusion criteria will be screened in the study. After passing the eligibility criteria, subjects will be randomized to receive F-Bioticâ„¢  or placebo once a day, 30 minutes before meals for 12 weeks.  Assessments as per the procotol will be performed at all visits. Blood samples will be collected for biomarker analysis and safety assessments.
 
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