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CTRI Number  CTRI/2024/12/078418 [Registered on: 23/12/2024] Trial Registered Prospectively
Last Modified On: 18/12/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Clinical study of Berberine extract in type 2 diabetes mellitus. 
Scientific Title of Study   A randomized, double-blind, parallel-arm clinical trial to assess the efficacy and safety of Berberine extract in participants with type 2 diabetes mellitus. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MHC/CT/24-25/049 Version 1.00; dated 11 December 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ramshyam Agarwal 
Designation  Principal Investigator 
Affiliation  Lokmanya Medical Research Centre and Hospital 
Address  Fourth floor OPD room no 401 314 B Telco Road Chinchwad

Pune
MAHARASHTRA
411033
India 
Phone  8087282022  
Fax  -  
Email  ramshyam.research@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gayatri Ganu 
Designation  Director 
Affiliation  Mprex Healthcare Pvt Ltd 
Address  Office no 501, 514 Crossroads building, Bhumkar square, Wakad

Pune
MAHARASHTRA
411057
India 
Phone  8554912644  
Fax  -  
Email  drgayatri@mprex.in  
 
Details of Contact Person
Public Query  
Name  Mr Vedant Gupta 
Designation  Director 
Affiliation  Konark Herbals and Healthcare Pvt Ltd 
Address  335B, Adhyaru Industrial Estate, Sunmill Compound, Lower Parel west

Mumbai
MAHARASHTRA
400013
India 
Phone  2261475300  
Fax  -  
Email  vrg@konarkgroup.com  
 
Source of Monetary or Material Support  
Konark Herbals and Healthcare Pvt. Ltd.335B, Adhyaru Industrial Estate, Sunmill Compound, Lower Parel West Mumbai 400013, Maharashtra 
 
Primary Sponsor  
Name  Konark Herbals and Healthcare Pvt. Ltd. 
Address  335B, Adhyaru Industrial Estate, Sunmill Compound, Lower Parel West, Mumbai 400013, Maharashtra 
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 Ramshyam Agarwal  Lokmanya Medical Research Centre and Hospital  Fourth Floor OPD room no 401 314 B Telco Road Chinchwad
Pune
MAHARASHTRA 		 8087282022
-
ramshyam.research@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Lokmanya Medical Research Centre  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 
Intervention  Berbabsorb high dose 1000 mg   2 capsules thrice daily after a meal + Oral hypoglycemic agents (OHA) for 90 Day 
Intervention  Berbabsorb low dose 750 mg  2 capsules thrice daily after a meal + Oral hypoglycemic agents (OHA) for 90 days 
Intervention  Lipokon® Berberine 500 mg   2 capsules thrice daily after a meal + Oral hypoglycemic agents (OHA) for 90 days 
Comparator Agent  Standardized extract of Berberine 500 mg  2 capsules thrice daily after a meal + Oral hypoglycemic agents (OHA) for 90 days. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Male and female participants between age 30-65 years (both inclusive);2. Participants receiving oral hypoglycemic agents (OHA) biguanides and sulfonylureas (only combination) Newly diagnosed participants who are eligible for inclusion may begin the trial with investigational product monotherapy. In the event of poor glycemic control, or safety concerns, the investigator may initiate standard-of-care treatment for type 2 diabetes mellitus;3. Glycated haemoglobin (HbA1c) greater than 6.5% and less than 8% (both inclusive);4. Fasting Plasma Glucose (FPG) greater than 130 mg/dL and less than 250 mg/dL (both inclusive);5. Participants willing to comply with the study procedure and sign written informed consent;6. Participants with a BMI of more than 28 and less than 35 kg/m2;7. Participants with or without deranged lipid profile. 
 
ExclusionCriteria 
Details  1.Type 1 diabetes;
2.Receiving antidiabetic drugs except for those specified in the inclusion criteria including Insulin treatment;
3.Participants with concurrent serious hepatic dysfunction (defined as AST and/or ALT greater than 3 times of the upper normal limit) or renal dysfunction (defined as S. creatinine greater than 1.4 mg/dl), uncontrolled pulmonary dysfunction (asthmatic and COPD patients) or other concurrent severe disease;
4.Participants suffering from major systemic illness necessitating long-term drug treatment including but not limited to hematologic conditions (eg, hemolytic anemias, sickle cell anemia), acute myocardial infarction, unstable angina, uncontrolled hypertension, congestive heart failure (class III or class IV NYHA), or cerebrovascular accident, psychiatric or neurological disorder, autoimmune condition, received chronic (grater than 14 days) therapy with systemic glucocorticoids (excluding topical, intraocular, intranasal, intra-articular, or inhaled preparations) within six months prior to enrollment;
5.Smokers or Alcoholics and or drug abusers;
6.Participants with evidence or history of malignancy;
7.Involvement in any other clinical trial requiring drug therapy;
8.Pregnant or lactating women or women of fertile age not using effective contraception;
9.Any condition that could, in the opinion of the investigator, preclude the participants ability to complete the study or that may confound study outcomes. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Changes in Glycemic profile by assessing
a) Fasting, and post-meal plasma glucose levels
from screening to the end of the study and
b) HbA1c levels at screening and end of the
study.
2.Changes in Insulin resistance by assessing
Fasting insulin, HOMA-IR score at screening and
end of the study. 		 At Screening, Day 30, Day 60, Day 90. 
 
Secondary Outcome  
Outcome  TimePoints 
1.Changes in lipid metabolism by assessing
cholesterol, LDL, HDL, Triglycerides etc., at
screening & end of the study.
2.Changes in Metabolic Syndrome Severity Z
Score (MetZ score) at screening & end of the
study.
3.Changes in anthropometric parameters like
body weight, BMI, & waist circumference from
screening to end of the study.
4.Changes in diabetes-related quality of life
score assessed by DQOL questionnaire score to
assess quality of life at screening & end of the
study. 		 At Screening, Day 30, Day 60, Day 90 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "86"
Final Enrollment numbers achieved (India)="86" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   08/01/2025 
Date of Study Completion (India) 29/05/2025 
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  

T2DM is a chronic metabolic disorder characterized by insulin resistance and hyperglycemia, leading to various complications affecting multiple organ systems. Despite the availability of OHAs, achieving and maintaining glycemic control in T2DM patients remains a challenge. Therefore, there is a continuous need for novel therapeutic approaches that can effectively manage T2DM while minimizing adverse effects and improving patients’ quality of life.

Berberine, a plant-derived alkaloid, has shown promising effects in improving glycemic control and insulin sensitivity in preclinical and clinical studies. However, there is limited evidence from well-designed clinical trials assessing its safety and efficacy in T2DM patients, especially when used as an adjuvant to existing OHAs.

This randomized, double-blind, parallel arm, interventional, prospective clinical trial aims to address this gap in knowledge by evaluating the safety and efficacy of standardized extract of berberine supplementation in the management of T2DM. Investigating four different formulations of berberine i.e. Berbabsorb high dose- 1000mg, Berbabsorb low dose-750mg, Standardized extract of Berberine 500 mg, and Lipokon® Berberine 500 mg allow for dose-response evaluation and identification of the optimal therapeutic dose.

The study incorporates a wide range of outcome measures, including glycemic profile, insulin resistance, lipid metabolism, metabolic syndrome severity, anthropometric parameters, diabetes-related quality of life, and safety assessment. By examining multiple endpoints, the study provides a holistic evaluation of Berberine’s impact on various aspects of T2DM management.

This clinical trial addresses the need for evidence-based adjunctive therapies in T2DM management by investigating the efficacy and safety of Berberine extract. The study’s design, including dose optimization, enhances the robustness and reliability of the findings, ultimately contributing to informed clinical decision-making and improved patient outcomes in T2DM care.


 
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