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CTRI Number  CTRI/2024/07/070781 [Registered on: 18/07/2024] Trial Registered Prospectively
Last Modified On: 26/08/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Crossover Trial 
Public Title of Study   A Single Dose Two-Way Crossover Oral Bioavailability Study Of The Study Product (BerbiQ) Which Contains Berberine, In Healthy, Adult, Human Subjects Under Fasting Conditions. 
Scientific Title of Study   A Double-Blind, Randomized, Single Dose, Two-Treatment, Two-Way Crossover, Oral Bioavailability Study of Investigational Product (Berbiq) Containing Berberine, In Healthy, Adult, Human Subjects Under Fasting Conditions. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
VCR-CSP-24/006 version 1.0 dated 25Jun2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ambanna Gowda 
Designation  Consultant Physician 
Affiliation  Unitree Health Care Diagnostics 
Address  Unitree Health Care Diagnostics at 38/1 Church Road Marappa Garden J C Nagar Bengaluru

Bangalore
KARNATAKA
560006
India 
Phone  9845270377  
Fax  -  
Email  gowdaambanna@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ambanna Gowda 
Designation  Consultant Physician 
Affiliation  Unitree Health Care Diagnostics 
Address  Unitree Health Care Diagnostics at 38/1 Church Road Marappa Garden J C Nagar Bengaluru


KARNATAKA
560006
India 
Phone  9845270377  
Fax  -  
Email  gowdaambanna@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shalini Dayananda 
Designation  Project Manager 
Affiliation  Vivatiq Clinical Research 
Address  358/274, Srigandha Nagar Main Road, Hegganahalli, Vishwaneedam Post, near Peenya Industrial Area 2nd stage Bangalore
-
Bangalore
KARNATAKA
560079
India 
Phone  9980107723  
Fax  -  
Email  vivatiqcr@gmail.com  
 
Source of Monetary or Material Support  
Molecules Biolabs Private Limited 
 
Primary Sponsor  
Name  Molecules Biolabs Pvt Ltd 
Address  Building No: III/634 First Floor, Commercial Building Kinfra Small Industrial Park, Koratty Kerala 680309, India  
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Ambanna Gowda  Unitree Health Care Diagnostics  Consultant Room 1, 38/1, Church Road, Marappa Garden, J C Nagar, Bengaluru 560006, Karnataka, India
Bangalore
KARNATAKA 		 9845270377

gowdaambanna@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ACE Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Metabolic health 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Berberine Capsule  a single oral dose, 1 capsule, (300 – 350 mg capsule containing NLT 250 mg of Berberine. 
Comparator Agent  Conventional Berberine Capsule  a single oral dose, 1 capsule, (300 – 350 mg capsule containing NLT 250 mg of Berberine 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1.Normal, healthy, adult, male and female Human participants of age between 18-45 years with a Body Mass Index range between 18.50 kg/m2 to 24.99 kg/m2.
2.Subject agrees to avoid high activity physical exercise 72.00 hours prior to last visit
3.Subjects who have no evidence of underlying disease during screening and check- in and whose screening is performed within 29 days of check in.
4.Subjects generally healthy as documented at screening considered by the physician or principal or clinical investigator.
5.Healthy as documented by the medical history, physical examination including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory, musculoskeletal and central nervous systems and vital sign assessments.
6.Non- smokers or ex-smokers. Ex-smokers are defined as someone who has completely stopped smoking for at least the past 03 months.
7.Willing to comply to all requirements of this study protocol as well as instructed by the study personnel
8.Generally healthy as documented by gynecological examination and breast examination -for female subjects during Period-I check-in only.
9.Female subjects of childbearing potential;
a.Practicing an acceptable non-hormonal contraceptive method of birth control after consulting with principal investigator; and/or
b.Surgically sterile - bilateral tubal ligation 
 
ExclusionCriteria 
Details  1.Evidence of allergy or known hypersensitivity to Berberine or other related drugs or other related drugs.
2.Subjects with hepatic encephalopathy, cholestasis, myasthenia, pre-existing liver disease, alcohol abuse, existing tinnitus, renal or liver impairment and pre-existing gallbladder disease.
3.Any major illness in the last three months or any significant ongoing chronic medical illness.
4.Any disease or condition which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, Musculoskeletal, respiratory, central nervous system, diabetes, psychosis or any other body system.
5.History of alcohol addiction or abuse.
6.Malabsorption syndrome that affects Berberine metabolism.
7.Heart failure, angina pectoris, ventricular arrhythmias or atrial fibrillation with more than100 per min ventricular rate.
8.Gastrointestinal bleeding in past three months.
9.Uncontrolled diabetes mellitus.
10.Active psychiatric disorder, intention for suicidal, disorders with Unconsciousness.
11.Psychopathic disorder, lack of cooperation.
12.Chronic obstructive lung disease or active smoking -more than 2 cigarettes in the past 6 months
13.Consumption of caffeine and or Xanthine containing products i.e., coffee, tea, chocolate, and caffeine-containing sodas, colas, etc., tobacco containing products for at least 24.00 hours prior to check-in and throughout the entire study
14.Consumption of grapefruit and its juice and poppy containing foods for at least 72.00 hours prior to check-in and throughout the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the oral bioavailability of investigational product 250 mg of Berberine Capsule) of Molecules BioLabs Private Limited, and the reference product 250 mg of conventional Berberine capsule of Molecules BioLabs Private Limited in healthy, adult, human subjects under fasting conditions.  pre dose and at 00.50, 01.00, 02.00, 06.00,12.00, 24.00 and 48 hours.  
 
Secondary Outcome  
Outcome  TimePoints 
To monitor the adverse events and to ensure the safety of the subjects.  screening and end of study. 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   27/07/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  will be updated upon study completion

  6. For how long will this data be available start date provided 25-10-2024 and end date provided 25-02-2025?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The risk of developing the metabolic syndrome, and its course severity, can be reduced by eliminating risk factors, such as an inappropriate diet, physical inactivity, stress, anxiety-depressive disorders, personality disorders, and the resulting behavioral addictions. The fight against this complex disease also involves the treatment of identified dis- orders within the metabolic syndrome, such as atherogenic dyslipidemia (hypertriglyceridemia and lowering LDL cholesterol), as well as the treatment of the repercussions of the metabolic syndrome, such as atherosclerosis, diabetic feet, liver cirrhosis due to non-alcoholic or alcoholic steatohepatitis, acute or chronic pancreatitis, local or general immunodeficiencies, and tendency for recurrent infections. 
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