| CTRI Number |
CTRI/2025/08/092616 [Registered on: 07/08/2025] Trial Registered Prospectively |
| Last Modified On: |
30/04/2026 |
| 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
|
|
|
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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other 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: It is a single Arm, |