| CTRI Number |
CTRI/2025/08/093684 [Registered on: 26/08/2025] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Comparing Salmusta Yoga and Metformin tablets in Adults between age group 31 to 60 years in type II Diabetes mellitus Madhumeha for improving Blood Sugar Control |
|
Scientific Title of Study
|
Evalutaion of Comparative Efficacy of Salmusta Yoga versus Tablet Metformin in the management of Diabetes mellitus type II Madhumeha 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 |
Diksha Gaikwad |
| Designation |
PG Scholar |
| Affiliation |
Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod Hirapur Wardha Maharashtra |
| Address |
Room no 30 Department of Kayachiktsa Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod Hirapur Wardha Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
9511256345 |
| Fax |
|
| Email |
diksha.gaikwad550@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Diksha Gaikwad |
| Designation |
PG Scholar |
| Affiliation |
Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod Hirapur Wardha Maharashtra |
| Address |
Room no 30 Department of Kayachiktsa Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod Hirapur Wardha Maharashtra
MAHARASHTRA
442001
India |
| Phone |
9511256345 |
| Fax |
|
| Email |
diksha.gaikwad550@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sadhana Misar Wajpeyi |
| Designation |
Professor and Head of Department |
| Affiliation |
Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod Hirapur Wardha Maharashtra |
| Address |
Room no 30 Department of Kayachiktsa Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod Hirapur Wardha Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
9763732083 |
| Fax |
|
| Email |
wajpeyisadhana@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod Hirapur Wardha Maharashtra 442001 |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod Hirapur Wardha Maharashtra |
| Address |
Room no 30 Department of Kayachikitsa Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod Hirapur Wardha Maharashtra 442001 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Diksha Gaikwad |
Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod Hirapur Wardha |
Room no 30 Department of Kayachikitsa Mahatma Gandhi Ayurveda College Hospital and Research Centre Salod Hirapur Wardha Maharashtra
Wardha
MAHARASHTRA |
9511256345
diksha.gaikwad550@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Ayurveda College Hospital and Research Centre Institutional Ethics 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 | Comparator Arm (Non Ayurveda) | | - | Metformin | Metformin is used for type 2 diabetes mellitus. It helps to control blood glucose levels. It is often used as a first line drug.
Dose : 500 mg
Frequency : BID
Route of Administration : oral
Total duration : 60 days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Salmusta Yoga, Reference: Yogratnakar, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: Crushed tablets before meal with madhu |
|
|
|
Inclusion Criteria
|
| Age From |
31.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to Participate with written informed consent
Age group 31 to 60 years of either gender
Criteria for diagnosis DM by American Diabetes Association
Fasting blood sugar level FBS greater than or equal to 126mg per dl upto 375mg per dl and or
Postprandial Blood Sugar Level PPBS greater than or equal to 200mg per dl upto 500mg per dl
Newly Diagnosed cases
|
|
| ExclusionCriteria |
| Details |
Known cases of
Insulin Dependent Diabetes mellitus and those who are under Insulin therapy
Patients with Chronic Diabetes complications like Nephropathy Neuropathy and Retinopathy
Patients with juvenile diabetes
Pregnant and Lactating women
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the efficacy of salmusta yoga followed by metformin over reduction of fasting and postprandial blood sugar level |
at baseline 30 days and 60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison and Assessment of efficacy of Salmusta Yoga followed by metformin over reduction of fasting and postprandial blood sugar level |
30 days and 60 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
11/12/2025 |
| 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="2"
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
|
The volunteers will be informed about the study protocol. Willing participants will be randomly selected as per computer generated table. Clinical research format will be prepared and validated. Prior to the study approval will be taken from IEC , MGACHRC, Salod Hirapur Wardha and CTRI registration will be done. After selection each participant will be tested individually and selected according to selection criteria. They are divided into two groups the trials is a randomized open label standard control equivalence clinical trial. It will be include 60 days treatment period and at day follow up period 0th , 30th and 60th days. |