| CTRI Number |
CTRI/2025/12/098567 [Registered on: 05/12/2025] Trial Registered Prospectively |
| Last Modified On: |
15/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Bramhi vati in the management of diabetes mellitus (madhumeha) as an add on to tab metformin |
|
Scientific Title of Study
|
Evaluation of comparative Efficacy of Tablet Metformin versus Brahmi vati (Bacopa monnieri Linn.) as an adjunct to Tablet Metformin in the management of Madhumeha (Diabetes mellitus type 2) –A Randomized Controlled Trial. |
| 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 ASHISH C ZANWAR |
| Designation |
Assistant Professor, department of kayachikitsa |
| Affiliation |
Mahatma Gandhi Ayurved College, Hospital And Research Centre |
| Address |
Department of Kayachikitsa
Sau. Shantadevi V. Patil Ayurved College, Hatta, tq. Basmat, Dist. Hingoli
at post Salod (H),
Tq.and Dist Wardha
Wardha
MAHARASHTRA
431542
India |
| Phone |
9404631455 |
| Fax |
|
| Email |
draczanwar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sadhana Misar |
| Designation |
Professor and HOD |
| Affiliation |
Mahatma Gandhi Ayurved College, Hospital And Research Centre |
| Address |
Department of Kayachikitsa
Mahatma Gandhi Ayurveda college, Hospital and research Centre
at post Salod (H),
Tq.and Dist Wardha
at post Salod (H),
Tq.and Dist Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9763732083 |
| Fax |
|
| Email |
sadhanamisar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ASHISH C ZANWAR |
| Designation |
Assistant Professor, department of kayachikitsa |
| Affiliation |
Mahatma Gandhi Ayurved College, Hospital And Research Centre |
| Address |
Department of Kayachikitsa
Sau. Shantadevi V. Patil Ayurved College, Hatta, tq. Basmat, Dist. Hingoli
at post Salod (H),
Tq.and Dist Wardha
Wardha
MAHARASHTRA
431542
India |
| Phone |
9404631455 |
| Fax |
|
| Email |
draczanwar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Ashish Zanwar |
| Address |
Dept Of Kayachiktsa,
Sau Shantadevi V Patil Ayurved College, Hatta, Tq. Basmat, Dist. Hingoli |
| Type of Sponsor |
Other [SELF] |
|
|
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 Ashish C Zanwar |
Mahatma Gandhi Ayurved College Hospital and Research Centre, |
Department of kayachikitsa , Salod (H), Wardha.
Wardha
MAHARASHTRA |
9404631455
draczanwar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Bramhi vati, Reference: bhavpraksh niganthu, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | tab metformin 500mg BID | 500 mg twice a day before meal |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects willing to give written informed consent
Patients having Aged 30-60
Either GendeR Newly Diagnosed with type 2 DM within the 6 months.
Blood Sugar (Fasting) - More than 126 mg per dl - less than 200 mg per dl
Blood Sugar (Post Parandial) - more than 200 mg/dl - less than 400mg/dl
HBA1c - more than 6.5 % - less than 8 % |
|
| ExclusionCriteria |
| Details |
Insulin Dependent Diabetes mellitus (IDDM-Type1)
• Gestational and juvenile diabetes mellitus
• With Diabetic complications (nephropathy, neuropathy, retinopathy, Gangrene, Ketoacidosis )
• Pregnant /Lactating Women
• uncontrolled and Malignant Hypertension
• H/o unstable angina, MI, cardiovascular accidents, renal failure
Allergy to medication
Pre and post operative with in 1 month.
Serious illness or bed ridden patient
Patient on Steroid Therapy
Patient on antipsychotic treatment |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Blood sugar level Fasting and post prandial HbA1c |
at 0 day , 30 day , 60 day and 90 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the occurrence of diabetes mellitus type 2 (Madhumeha) as per Prakruti.
2. To assess the efficacy of Metformin with Brahmi vati & Metformin on Agni & Koshtha.
To compare the efficacy of Metformin with Brahmi vati & Metformin on Agni & Koshtha. |
at 0 day & 90 day |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
11/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Whether Tablet Metformin is more efficacious Brahmi vati (Bacopa monnieri Linn.) as add on to Tablet Metformin in the management of Madhumeha (Diabetes mellitus type 2) to find an additional treatment modality for the managment of madhumeha with ayurveda |