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CTRI Number  CTRI/2025/10/096067 [Registered on: 14/10/2025] Trial Registered Prospectively
Last Modified On: 30/04/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Single Arm Study 
Public Title of Study   Efficacy and Safety BerBerista in the management of Obesity 
Scientific Title of Study   An Open Label Clinical Study to Evaluate the Efficacy and Safety BerBeristaTM on Obesity Management in Healthy Volunteers 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
BL/DHB/004 Version 1.0; Dated 19 September, 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Giri Raja KV 
Designation  Consultant General Physician 
Affiliation  Rajalakshmi Hospital and Research Center 
Address  21/1 Lakshmipura Main Road Vidyaranyapura Post Bangalore

Bangalore
KARNATAKA
560097
India 
Phone  08023254855  
Fax    
Email  drgirirajkv@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Amal Maji 
Designation  Scientist 
Affiliation  BIORADIAN LIFESCIENCE 
Address  Sonamui Market Place Goura Medinipur

Medinipur
WEST BENGAL
721146
India 
Phone  08697612674  
Fax    
Email  amal.bioradian@gmail.com  
 
Details of Contact Person
Public Query  
Name  Mr Manik Chaudhuri 
Designation  Project Manager 
Affiliation  BIORADIAN LIFESCIENCE 
Address  No 7/1 AGB Layout 5th Cross 1st Main Nandini Layout Bangalore

Bangalore
KARNATAKA
560096
India 
Phone  9738651205  
Fax    
Email  mc.bioradian@gmail.com  
 
Source of Monetary or Material Support  
M R HEALTHCARE PVT LTD Tanda Mallu, Kashipur Road Ramnagar, Nanital, Uttarakhand India 244715 
 
Primary Sponsor  
Name  M R HEALTHCARE PVT LTD 
Address  Tanda Mallu, Kashipur Road Ramnagar, Nanital, Uttarakhand India 244715 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
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 Giri Raja KV  Rajalakshmi Hospital and Research Center  Dept of General Medicine, Rooms No 1, Ground Floor, 21/1 Lakshmipura Main Road Vidyaranyapura Post Bangalore 560097
Bangalore
KARNATAKA 		 08023254855

drgirirajkv@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Rajalakshmi Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E669||Obesity, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  BerBerista Powder  BerBerista powder 500 mg twice daily for 90 days 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Subjects of either sex between 18 to 50 years of age;
Subject with BMI range 26-32;
Ability of the subject to understand the risks and benefits of the study;
Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, or double-barrier and have a negative pregnancy test at the Screening Visit. Female subjects of non-childbearing potential must be amenorrhoeic for at least one year or had a hysterectomy and/or bilateral oophorectomy;
Willingness to participate in a walking-exercise program (5 days a week, 30 min per day) with the scheduled timing per week during the study period;
Subject agrees to consume a healthy vegetarian or non-vegetarian diet;
Subject should be available for duration of study period (three months);
Subjects agree to come to site in fasting state for their weight measurements and other laboratory parameters examination in all the scheduled visits;
Subject using other therapies for weight management including physiotherapy or occupational therapy agrees to discontinue these therapies during this study;
Subject agrees not to start any new therapies for weight loss during the study period;
Subjects agree to maintain the activity dairy;
Willing to give written informed consent and willing to comply with trial protocol 
 
ExclusionCriteria 
Details  Subjects suffering from intractable obesity, has defined weight limits, or have experienced any recent, unexplained weight loss or gain;
Having history of underlying inflammatory arthropathy, septic arthritis, gout, inflammatory joint disease, joint fracture, or rheumatoid arthritis, thyroid disease, liver, or kidney diseases, and hypertension;
Having history of asthma, cardiovascular diseases, coagulopathies, diabetes (Type I or Type II);
History of high alcohol intake (2 standard drinks per day);
History of psychiatric disorder that may impair the ability of subjects to provide written informed consent and increase the risk of adverse events or interfere with study assessments;
Subjects, who are pregnant, breast feeding or planning to become pregnant during the study;
Immunocompromised subjects or subjects with steroids or immunomodulators;
Patients of vulnerable group (lactating mother, handicapped, seriously ill or mentally challenged);
Any other condition that, in the opinion of the investigator, would adversely affect the subject’s ability to complete the study or its measures;
Participated in any investigational study medication within thirty (30) days prior to screening;
Known allergy to compounds of investigational product 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Mean change in body Weight and BMI from baseline to different study visits  At baseline, Day 30, Day 60 and Day 90 
 
Secondary Outcome  
Outcome  TimePoints 
Change from the baseline in waist circumference, waist to hip ratio , Complete Blood Count, Liver Function Test (SGOT), Renal Function Test (Creatinine), Random Blood Sugar, Total Cholesterol and Triglyceride, Incidence of treatment-related adverse events  Day 1 to Day 90 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   30/10/2025 
Date of Study Completion (India) 02/01/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This open-label, interventional clinical study is designed to evaluate the efficacy and safety of BerBerista (500 mg twice daily) in the management of obesity among 20 healthy volunteers over a 90-day treatment period. The primary objectives are to determine the percentage change in body weight and improvement in Body Mass Index (BMI) compared to baseline. Secondary objectives include assessing changes in anthropometric measurements (waist circumference and waist-to-hip ratio), monitoring laboratory parameters (CBC, LFT, RFT, RBS, lipid profile), and recording adverse events throughout the study. Eligible participants are 18 to 50 years old with a BMI 26 to 32, willing to adhere to a healthy diet, maintain a 30-minute walking exercise program five days per week, and comply with study procedures, including maintaining dietary and activity diaries. Individuals with major systemic illnesses, metabolic disorders (such as diabetes or thyroid disease), cardiovascular conditions, or recent investigational drug use will be excluded. The study consists of four visits: Screening/Baseline at Day 1, telephonic follow-ups at Day 30 and Day 60, and an end-of-study visit at Day 90. Key assessments include weight, BMI, anthropometric measurements, laboratory safety tests, and adverse event monitoring.

 
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