| CTRI Number |
CTRI/2025/09/095004 [Registered on: 17/09/2025] Trial Registered Prospectively |
| Last Modified On: |
13/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A CLINICAL TRIAL TO EVALUATE THE EFFECT OF MEHMUDGAR VATI WITH AND WITHOUT GOAT MILK IN MADHUMEHA (NIDDM) |
|
Scientific Title of Study
|
COMPARATIVE CLINICAL EVALUATION OF MEHMUDGAR VATI WITH AND WITHOUT GOAT MILK IN MADHUMEHA (NIDDM) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KEERTI BENJWAL |
| Designation |
PG SCHOLAR |
| Affiliation |
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN HARIDWAR DELHI HIGHWAY UTTARAKHAND |
| Address |
DEPARTMENT OF KAYACHIKITSA, OPD NO. 13/14, PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN HARIDWAR UTTARAKHAND
DEPARTMENT OF KAYACHIKITSA, OPD NO. 13/14, PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN HARIDWAR UTTARAKHAND
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9997819623 |
| Fax |
|
| Email |
keerti.benjwal2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VIKRAM GUPTA |
| Designation |
PROF MD(Ayu) |
| Affiliation |
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN HARIDWAR DELHI HIGHWAY UTTARAKHAND |
| Address |
DEPARTMENT OF KAYACHIKITSA, OPD NO. 13/14, PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN HARIDWAR UTTARAKHAND
DEPARTMENT OF KAYACHIKITSA, OPD NO. 13/14, PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN HARIDWAR UTTARAKHAND
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8958640973 |
| Fax |
|
| Email |
vdvikram20@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR VIKRAM GUPTA |
| Designation |
PROF MD(Ayu) |
| Affiliation |
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN HARIDWAR DELHI HIGHWAY UTTARAKHAND |
| Address |
DEPARTMENT OF KAYACHIKITSA, OPD NO. 13/14, PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN HARIDWAR UTTARAKHAND
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN HARIDWAR DELHI HIGHWAY UTTARAKHANDDEPARTMENT OF KAYACHIKITSA, OPD NO. 13/14, PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN HARIDWAR UTTARAKHAND
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8958640973 |
| Fax |
|
| Email |
vdvikram20@gmail.com |
|
|
Source of Monetary or Material Support
|
| PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN HARIDWAR DELHI HIGHWAY UTTARAKHAND |
|
|
Primary Sponsor
|
| Name |
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN HARIDWAR |
| Address |
PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN HARIDWAR DELHI HIGHWAY UTTARAKHAND |
| Type of Sponsor |
Private medical college |
|
|
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 |
| KEERTI BENJWAL |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
Department of Kayachikitsa, OPD no. 13/14, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Delhi Haridwar Highway, 249405, Uttarakhand
Hardwar
UTTARANCHAL |
9997819623
keerti.benjwal2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN, HARIDWAR, UTTARAKHAND |
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: Mehmudgar Vati , Reference: Bheshajya Ratnavali 92-95, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -With Goat milk), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Mehmudgar Vati , Reference: Bheshajya Ratnavali 92-95, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -With Lukewarm water ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients having Fasting Blood Sugar Level between 126-140 mg/dL and/or Post Prandial Blood Sugar Level more than 140-200 mg/dL ·
B.M.I. in between 25-30 kg/m2 (Overweight Criteria According to W.H.O. Classification of Obesity).
Age between 30-65 of either gender ·
Those who are ready to sign informed consent form and follow treatment protocol.
|
|
| ExclusionCriteria |
| Details |
Fasting Blood sugar level more than 140 mg/dl ·
Post Prandial Blood Sugar Level more than 200 mg/dl ·
Pregnant and lactating women.
Patients with chronic complications like Nephropathy, Retinopathy and Neuropathy.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Polyuria
Turbid urine
Dryness of throat and mouth
Burning sensations in hands and feet
Sweating
Fatigue
Sweet taste of mouth |
0 Days 15th Days 30th Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in symptoms such as polyuria. dryness of throat and palate, burning sensation in hands and feet, excessive sweating, fatigue, sweet taste in mouth |
0 Days 15th Days 30th 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 2 |
|
Date of First Enrollment (India)
|
29/09/2025 |
| 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="1"
Months="6"
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
|
This study is a comparative clinical study to evaluate the effect of Mehmudgar vati 250 mg twice daily after meal with and without goat milk for 18 months in 60 patients in Madhumeha (NIDDM) that will be conducted in OPD no. 13/14 in Patanjali Ayurvedic Hospital , Haridwar |