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CTRI Number  CTRI/2025/08/092131 [Registered on: 01/08/2025] Trial Registered Prospectively
Last Modified On: 30/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Nutraceuticals]  
Study Design  Randomized, Crossover Trial 
Public Title of Study   A Double Blind Single Dose Three Period Oral Pharmacokinetic Study Comparing Berberine HCl in Healthy Adult Human Subjects under Fasting conditions 
Scientific Title of Study   A Double Blind Balanced Randomized Single Dose Three Arm Three Sequence Three Period Three Way Crossover Oral Pharmacokinetic Study Comparing Berberine HCl 40% with Natural Additives Berberine HCl 40% with Natural Additives and Probiotics and Berberine HCl 95% in Healthy Adult Human Subjects under Fasting conditions 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
SLS-CT-0012-25-BERB Version No 01 Date 11 Jul 25  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pradeep T 
Designation  Principal Investigator 
Affiliation  Spinos Lifescience and research private limited 
Address  Clinical Pharmacology unit Ground Floor No 29 A Krishna Maduravanam Vellakinar pirivu Thudiyalur Coimbatore

Coimbatore
TAMIL NADU
641029
India 
Phone  08220586899  
Fax    
Email  pradeep.t@spinoslifescience.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pradeep T 
Designation  Principal Investigator 
Affiliation  Spinos Lifescience and research private limited 
Address  Clinical Pharmacology unit Ground Floor No 29 A Krishna Maduravanam Vellakinar pirivu Thudiyalur Coimbatore


TAMIL NADU
641029
India 
Phone  08220586899  
Fax    
Email  pradeep.t@spinoslifescience.com  
 
Details of Contact Person
Public Query  
Name  Dr Pradeep T 
Designation  Principal Investigator 
Affiliation  Spinos Lifescience and research private limited 
Address  Clinical Pharmacology unit Ground Floor No 29 A Krishna Maduravanam Vellakinar pirivu Thudiyalur Coimbatore


TAMIL NADU
641029
India 
Phone  08220586899  
Fax    
Email  pradeep.t@spinoslifescience.com  
 
Source of Monetary or Material Support  
India Glycols Ltd Plot 2 5 Selaqui 248197 Dehradun Uttarakhand India 
 
Primary Sponsor  
Name  India Glycols Ltd 
Address  Plot 2 5 Selaqui 248197 Dehradun Uttarakhand India 
Type of Sponsor  Other [Nutraceutical] 
 
Details of Secondary Sponsor  
Name  Address 
Spinos Life Science and Research Private limited  29 A Krishna Madhuravanam Vellakinar Pirivu Thudiyalur Coimbatore 641029 Tamil Nadu India  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pradeep T  Spinos Life science and Research private limited  Clinical Pharmacology unit Ground Floor No 29 A Krishna Maduravanam Vellakinar pirivu Thudiyalur Coimbatore 641029
Coimbatore
TAMIL NADU 		 08220586899

pradeep.t@spinoslifescience.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research Ethics Committee RegistrationNoECR/84/Indt/TN/2013/RR-24  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Fasting Conditions 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Berberine HCl 40% with natural additive  A Single oral dose of Berberine HCl 40% with natural additive will be administered in each period Total Duration is atleast 16 Days 
Intervention  Berberine HCl 40% with natural additives and Probiotics  A Single oral dose of Berberine HCl 40% with natural additives and Probiotics will be administered in each period Total Duration is atleast 16 Days 
Intervention  Berberine HCl 95%  A Single oral dose of Berberine HCl 95% will be administered in each period Total Duration is atleast 16 Days 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Normal healthy adult human male and female subjects of age between 18 45 years and Body Mass Index BMI ranges between 18.50 kg/m2 to 24.99. kg/m2
Subjects who have no evidence of underlying disease during screening and check in and whose screening is performed within 21 days of check in
Subjects whose screening laboratory values are within normal limits or considered by the physician or principal clinical investigator to be of no clinical significance
Healthy as documented by the medical history physical examination including but not limited to an evaluation of the cardiovascular gastrointestinal respiratory musculoskeletal and central nervous system and vital sign assessments
Generally healthy as documented by a 12 lead electrocardiogram Chest X Ray and clinical laboratory assessments
Willing to comply with all requirements of this study protocol as well as instructions from the study personnel
Non smokers who have abstained from tobacco use for at least 6 months prior to screening
Generally healthy as documented by gynaecological examination and breast examination period I only
Healthy individuals who were not currently undergoing treatment for any serious disease
Females of childbearing potential must have a negative serum pregnancy test performed within 21 days prior to the initiation of the study and a negative urine pregnancy test prior to check-in for each period
If the subject is female currently not pregnant not lactating or not attempting to become pregnant for 4 weeks before the screening visit throughout the duration of the study and 3 weeks after the subjects last study related visit for eligible subjects only if applicable has a negative serum pregnancy test and is of
non childbearing potential defined as
greater than or equal to 1 year post menopausal no menstrual period for at least 12 consecutive months without any other medical cause
Surgically sterile bilateral tubal ligation bilateral oophorectomy or hysterectomy
or is of
childbearing potential willing to commit to using a consistent and acceptable method of birth control as defined below for the duration of the study
double barrier methods condoms cervical cap diaphragm and vaginal contraceptive film with spermicide
or is of
childbearing potential and not sexually active willing to commit to using a consistent and acceptable method of birth control as defined above for the duration of the study in the event the subject becomes sexually active 
 
ExclusionCriteria 
Details  Evidence of allergy or known hypersensitivity to Berberine Hydrochloride or its inactive ingredients
Subjects with hepatic encephalopathy cholestasis myasthenia pre existing liver disease alcohol abuse existing tinnitus and pre existing gallbladder disease
Any major illness in the last three months or any significant ongoing chronic medical illness
Currently being treated for an infection with an antibiotic and or antiviral prescription medication and who used 01 month before check in
Renal or liver impairment
Any disease or condition that might compromise the haemopoeitic gastrointestinal renal hepatic cardiovascular Musculoskeletal respiratory central nervous system or any other body system including presence of Diabetes Mellitus and Psychosis
History of alcohol addiction or abuse
Consumption of caffeine and or xanthine containing products ie coffee tea chocolate caffeine containing sodas colas etc cigarettes and tobacco containing products for at least 48.00 hours prior to check in and throughout the entire study
Consumption of alcohol and its products grapefruit and or its juice and poppy containing foods within 48.00 hours prior to clinic admission and throughout the entire study
Subjects who have taken any prescription medications within 14 days prior to study check in and throughout the study and any over the counter medicinal products herbal medications supplements within 30 days prior to study check in and throughout the study
Subjects who have taken any unusual diet for whatever reason eg low salt for 48.00 hours prior to dosing and throughout the study.
Subjects with a history of participation in any other clinical study within 90 days preceding check in
History of difficulty in swallowing
History of difficulty in accessibility of veins
Positive results for urine screen of drugs of abuse in urine prior to check in of each period
Positive results for alcohol test prior to check in of each period
Any blood donation excess blood loss within 90 days of check in
Ingestion of any hormonal agent at any time within 14 days prior to the start of the study check in
Use of hormone replacement therapy for a period of 06 months prior to dosing
Female subjects demonstrating a positive pregnancy screen
Female subjects who are currently lactating
Females are likely to become pregnant during the course of the study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess and compare the Pharmacokinetics of three Berberine HCl Manufactured by India Glycols Ltd Plot 2 5 Selaqui 248197 Dehradun Uttarakhand India in Healthy Adult Human Subjects under Fasting conditions  15 Time Points
00 00 Hrs 00 25 Hrs 00 50 Hrs 00 75 Hrs 01 00 Hrs 02 00 Hrs 03 00 Hrs 04 00 Hrs 06 00 Hrs 08 00 Hrs 12 00 Hrs 18 00 Hrs 24 00 Hrs 36 00 Hrs and 48 00 Hrs 
 
Secondary Outcome  
Outcome  TimePoints 
To monitor the safety and tolerability of test products comparing in healthy adult human subjects under fasting conditions  15 Time Points
00 00 Hrs 00 25 Hrs 00 50 Hrs 00 75 Hrs 01 00 Hrs 02 00 Hrs 03 00 Hrs 04 00 Hrs 06 00 Hrs 08 00 Hrs 12 00 Hrs 18 00 Hrs 24 00 Hrs 36 00 Hrs and 48 00 Hrs 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" 
Phase of Trial   N/A 
Date of First Enrollment (India)   11/08/2025 
Date of Study Completion (India) 29/08/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   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  
At least 36 number of healthy adult human subjects will be recruited to evaluate the Pharmacokinetic of Test products
As per the discretion of the Investigator a sufficient number of stand by subjects will be included additionally to ensure successful dosing of 36 subjects in period I alone
In each period subjects will be housed in the clinical facility for at least 11.00 hours pre dose to 24.00 hours post dose
A washout period of at least 07 days will be maintained between each dosing period
In each period after an overnight fasting of at least 10.00 hours in the morning a single oral dose of either of the test products T will be administered as per the randomization schedule with 240 mL of drinking water at ambient temperature
Blood pressure, radial pulse rate body temperature and wellbeing status will be enquired and recorded at and 00.00 hour within 75 minutes of before dosing and at 01.00 03.00 06.00 and 12.00 hours ± 45 minutes post dose
Seated blood pressure radial pulse rate body temperature and wellbeing status will be enquired and recorded before the collection of the ambulatory sample at 36.00 and 48.00 hours ± 45 minutes post dose
Physical examination and vitals will be recorded before check in check out 24.00 hours ± 45 minutes for each period and at any time if necessary
Monitoring for adverse events will be done throughout the study period in clinical phase
 
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