| CTRI Number |
CTRI/2025/07/090721 [Registered on: 11/07/2025] Trial Registered Prospectively |
| Last Modified On: |
29/06/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Medha Vati Extra Power in Subjects suffering from Stress and Anxiety |
|
Scientific Title of Study
|
Clinical Effectiveness of Medha Vati Extra Power in the Management of Stress and Anxiety: 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 Rakesh Dehari |
| Designation |
Resident Medical Officer |
| Affiliation |
Patanjali Wellness |
| Address |
OPD No 22
Department of Panchkarma Patanjali Yogpeeth Maharshi Dayanand Gram Delhi Haridwar National Highway Near Bahadrabad Haridwar 249405 Uttarakhand India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7879701499 |
| Fax |
|
| Email |
drrakeshdehari2007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh Dehari |
| Designation |
Resident Medical Officer |
| Affiliation |
Patanjali Wellness |
| Address |
OPD No 22
Department of Panchkarma Patanjali Yogpeeth Maharshi Dayanand Gram Delhi Haridwar National Highway Near Bahadrabad Haridwar 249405 Uttarakhand India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7879701499 |
| Fax |
|
| Email |
drrakeshdehari2007@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rakesh Dehari |
| Designation |
Resident Medical Officer |
| Affiliation |
Patanjali Wellness |
| Address |
OPD No 22
Department of Panchkarma Patanjali Yogpeeth Maharshi Dayanand Gram Delhi Haridwar National Highway Near Bahadrabad Haridwar 249405 Uttarakhand India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7879701499 |
| Fax |
|
| Email |
drrakeshdehari2007@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 Rakesh Dehari |
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 |
7879701499
drrakeshdehari2007@gmail.com |
| Dr Rakesh Dehari |
Patanjali Wellness |
OPD No 22
Department of Panchkarma Patanjali Wellness Delhi Haridwar National Highway Near Bahadrabad Haridwar 249405 Uttarakhand India
Hardwar
UTTARANCHAL |
7879701499
drrakeshdehari2007@gmail.com |
| Dr Rakesh Dehari |
Patanjali Yoggram |
OPD No 16
Department of Panchkarma Patanjali Yoggram Yog Naturopathy Panchkarma Treatment and Research Centre Yoggram Village Aurangabad Near SIDCUL Roshnabad Haridwar 249402 Uttarakhand India
Hardwar
UTTARANCHAL |
7879701499
drrakeshdehari2007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| PATANJALI AYURVED COLLEGE ETHICS COMMITTEE |
Approved |
| PATANJALI AYURVED COLLEGE ETHICS COMMITTEE |
Approved |
| PATANJALI AYURVED COLLEGE ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F419||Anxiety disorder, unspecified. Ayurveda Condition: MANA-SANTAPAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Medha Vati Extra Power, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -With water ), Additional Information: - |
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with complaints of Stress and/or Anxiety.
Hamilton Anxiety Rating Scale total score 14 or higher at the screening.
Perceived Stress Scale PSS 10 score 13 or higher at the screening.
Subjects must provide written informed consent to participate in the study.
Willing to do regular follow up.
|
|
| ExclusionCriteria |
| Details |
Subjects with depressive episode, suicidal tendency obsessive compulsory disorder schizophrenia and mania.
Subjects with history of alcohol smoking tobacco or with any substance abuse.
Subjects with severe hepatic renal cardiovascular or respiratory disease.
Subjects with known Post Traumatic Stress Disorder and Generalized anxiety disorder and Anxiety neurosis.
Pregnancy or breastfeeding.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Stress and Anxiety assessed by the change in Depression Anxiety Stress Scales 21 scores. |
from baseline to day 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Stress and Anxiety assessed by the change in Perceived Stress Scale and Hamilton Anxiety Rating Scale scores |
from baseline to day 30 and Day 60 |
|
|
Target Sample Size
|
Total Sample Size="61"
Sample Size from India="61"
Final Enrollment numbers achieved (Total)= "73"
Final Enrollment numbers achieved (India)="73" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/07/2025 |
| Date of Study Completion (India) |
14/05/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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)
|
This is a prospective, open label, single arm, observational study. Subjects will be screened on the basis of Inclusion/Exclusion criteria and enrolled after obtaining written Informed consent. Eligible subjects will take the panchkarma (Shirodhara), naturopathy, diet, yoga (Pranayam and asans) and Medha Vati Extra Power Tablet for 7 days. On dischage patients will advise to contiune Medha vati Extra power tablet for next 60 days. The Improvement in Stress and Anxiety assessed by the change in Depression Anxiety Stress Scales 21 scores from baseline to Day 7 and day 60. In Perceived stress scale and Hamilton Anxiety Rating Scale from baseline to Day 30 and Day 60. |