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CTRI Number  CTRI/2025/08/092616 [Registered on: 07/08/2025] Trial Registered Prospectively
Last Modified On: 07/05/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Nutraceutical 
Study Design  Single Arm Study 
Public Title of Study   A Natural Approach to manage sugar levels Studying the Effects of Holistic Berberine in People with Type 2 Diabetes 
Scientific Title of Study   A Clinical Study To Evaluate The Efficacy Of Holistic Berberine In The Management Of Madhumeha(Type 2 Diabetes Mellitus) 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shyamanta Kalita  
Designation  HOD Associate Professor Department Of Kayachikitsa 
Affiliation  Govt Ayurvedic College and Hospital 
Address  OPD Room number 04 and IPD of Kayachikitsa Department,Govt. Ayurvedic College and Hospital, Jalukbari

Kamrup
ASSAM
781014
India 
Phone  7578890010  
Fax    
Email  kalitashyamanta108@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Shyamanta Kalita  
Designation  HOD Associate Professor Department Of Kayachikitsa 
Affiliation  Govt Ayurvedic College and Hospital 
Address  OPD Room number 04 and IPD of Kayachikitsa Department,Govt. Ayurvedic College and Hospital, Jalukbari

Kamrup
ASSAM
781014
India 
Phone  7578890010  
Fax    
Email  kalitashyamanta108@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shyamanta Kalita  
Designation  HOD Associate Professor Department Of Kayachikitsa 
Affiliation  Govt Ayurvedic College and Hospital 
Address  OPD Room number 04 and IPD of Kayachikitsa Department,Govt. Ayurvedic College and Hospital, Jalukbari

Kamrup
ASSAM
781014
India 
Phone  7578890010  
Fax    
Email  kalitashyamanta108@gmail.com  
 
Source of Monetary or Material Support  
Zeroharm Sciences Private Limited Unit No B 23, Phase 2 Technocrat, Cooperative Industrial Estate, Balanagar, Hyderabad, Telangana 500037, India 
 
Primary Sponsor  
Name  Zeroharm Sciences Private Limited 
Address  Unit No B 23, Phase 2 Technocrat, Cooperative Industrial Estate, Balanagar, Hyderabad, Telangana 500037, India 
Type of Sponsor  Other [Neutracutical Company ] 
 
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 Shyamanta Kalita   Govt. Ayurvedic College & Hospital   OPD Room number 04 and IPD of Kayachikitsa Department,Govt. Ayurvedic College and Hospital, Jalukbari Guwahati Assam, Pin- 781014, India Kamrup ASSAM
Kamrup
ASSAM 		 7578890010

kalitashyamanta108@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee Govt Ayurvedic College Jalukbari Guwahati Assam   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E118||Type 2 diabetes mellitus with unspecified complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Holistic Berberine, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 400(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with glycosylated hemoglobin HbA1c graterthan 6.5%.
Patients recently diagnosed with uncomplicated non-insulin-dependent diabetes mellitus type 2 diabetes
and having the following criteria fasting blood sugar level grater than 126 mg/dL and less than 250 mg/dL, and post-meal blood sugar level greaterthan 200 mg/dL. 
 
ExclusionCriteria 
Details  patients having age lower than 18 and higher than 70 years
patients are pregnant and lactating women
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.The patient will be assessed based on their body weight, BMI, Body circumference measurements of certain regions 2. Investigations: Complete Lipid profile, HbA1C  12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
1. Weight management (measured by BMI).
2. Quality of life (measured by the Short Form Health Survey - SF-36).
3. Dietary and lifestyle assessments through questionnaires. 		 12 weeks 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="50" 
Phase of Trial   N/A 
Date of First Enrollment (India)   18/08/2025 
Date of Study Completion (India) 15/04/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
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
Modification(s)  
Brief Methodology Single Arm open label prospective interventional study of Hoilstic Bereberine in 50 adults with Type 2 diabetes melilitus for 90 days. Primary outcomes FBS PPBS HbA1C secondary outcomes Madhumeha Lakshanas at Day 0 30 60 90

Results All 50 participants completed the study significant reductions FBS by 23.51 mg/dL PPBS by 41.19 mg/dL HbA1C from 7.96 to 6.48. Efficacy was age independent tiredness and fatigue resolved by Day 30 turbid urine and burning sensation resolved by day 90 No adverse events were observed

Conclusion Holistic Berberine produces highly significant reductions in FBS PPBS and HbA1C with a complete absence of adverse events and is recommended as a safe effective Ayurvedic therapeutic option for Type 2 Diabetes Mellitus.

 
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