| CTRI Number |
CTRI/2025/06/089660 [Registered on: 26/06/2025] Trial Registered Prospectively |
| Last Modified On: |
09/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Madhunashini Vati Extra Power in Diabetes Mellitus |
|
Scientific Title of Study
|
Effectiveness Assessment of Madhunashini Vati Extra Power in Type 2 Diabetes Mellitus: Prospective, Open Label, Single Arm, Observational Study |
| 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 Anurag Sharma |
| Designation |
Resident Medical Officer |
| Affiliation |
Patanjali Yoggram Yog Naturopathy Panchkarma Treatment and Research Centre |
| Address |
OPD No 13 Panchkarma Department Patanjali Yoggram Yog Naturopathy Panchkarma Treatment and Research Centre Yoggram Village Aurangabad Near SIDCUL Roshnabad Haridwar Uttarakhand India 249402
Hardwar
UTTARANCHAL
249402
India |
| Phone |
08171510464 |
| Fax |
|
| Email |
dr.anuragsharma1987@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anurag Sharma |
| Designation |
Resident Medical Officer |
| Affiliation |
Patanjali Yoggram Yog Naturopathy Panchkarma Treatment and Research Centre |
| Address |
OPD No 13 Panchkarma Department Patanjali Yoggram Yog Naturopathy Panchkarma Treatment and Research Centre Yoggram Village Aurangabad Near SIDCUL Roshnabad Haridwar Uttarakhand India 249402
UTTARANCHAL
249402
India |
| Phone |
08171510464 |
| Fax |
|
| Email |
dr.anuragsharma1987@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anurag Sharma |
| Designation |
Resident Medical Officer |
| Affiliation |
Patanjali Yoggram Yog Naturopathy Panchkarma Treatment and Research Centre |
| Address |
OPD No 13 Panchkarma Department Patanjali Yoggram Yog Naturopathy Panchkarma Treatment and Research Centre Yoggram Village Aurangabad Near SIDCUL Roshnabad Haridwar Uttarakhand India 249402
UTTARANCHAL
249402
India |
| Phone |
08171510464 |
| Fax |
|
| Email |
dr.anuragsharma1987@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Research Foundation Governed by Patanjali Research Foundation Trust
NH 58 Near Bahadrabad Haridwar 249405 Uttarakhand India |
|
|
Primary Sponsor
|
| Name |
Patanjali Research Foundation |
| Address |
NH 58 Near Bahadrabad Haridwar 249405 Uttarakhand India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anurag Sharma |
Patanjali Ayurveda Hospital |
OPD No 31
Department of Panchkarma Patanjali Yogpeeth Maharshi Dayanand Gram Delhi Haridwar National Highway Near Bahadrabad Haridwar 249405 Uttarakhand India
Hardwar
UTTARANCHAL |
08171510464
dr.anuragsharma1987@gmail.com |
| Dr Anurag Sharma |
Patanjali Wellness |
OPD 17
Department of Panchkarma Patanjali Wellness Delhi Haridwar National Highway Near Bahadrabad Haridwar 249405 Uttarakhand India
Hardwar
UTTARANCHAL |
08171510464
dr.anuragsharma1987@gmail.com |
| Dr Anurag Sharma |
Patanjali Yoggram |
OPD 13 Department of Panchkarma Patanjali Yoggram Yog Naturopathy Panchkarma Treatment and Research Centre Yoggram Village Aurangabad Near SIDCUL Roshnabad Haridwar 249402 Uttarakhand India
Hardwar
UTTARANCHAL |
08171510464
dr.anuragsharma1987@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PATANJALI AYURVED COLLEGE 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: PRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
HbA1C between 5.7 to 6.4
The subject is able and willing to provide consent
|
|
| ExclusionCriteria |
| Details |
Patients with Type 1 Diabetes Mellitus or on Insulin
Patients with Gestational diabetes
Pregnancy or lactation planning for pregnancy
Patients with uncontrolled HTN
Any condition the investigator identifies that can confound the participants ability to participate in the study properly
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in HbA1C |
baseline (Day 1) to Day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in The Revised Version of DQOL RV DQOL13 Questionnaire |
baseline (Day 1) to Day 90 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
08/07/2025 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 open label, single arm, prospective observational study will assess the effectiveness of Madhunashini Vati Extra Power in Type 2 Diabetes Mellitus patients. Patients will be screened on the basis of Inclusion/Exclusion criteria and enrolled after obtaining written Informed consent. The Patients will be followed-up for the next 90 days from the day of enrolment. Primary and secondary outcome will be evaluated by assessing HbA1C and the help of The Revised Version of DQOL (RV-DQOL13) |