| CTRI Number |
CTRI/2025/08/093910 [Registered on: 29/08/2025] Trial Registered Prospectively |
| Last Modified On: |
29/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Yoga Module and atis (herb)in overweight: An RCT |
|
Scientific Title of Study
|
Evaluating the Efficacy of Yoga Module and Aconitum heterophyllum Wall.Ex Royle (Atis) for the Management of Sthaulya (Overweight) with Comorbid Psychological Conditions: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| chaitrarawat186@gmail.com |
Other |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Km Mamta |
| Designation |
Research Scholar |
| Affiliation |
University of Patanjali |
| Address |
Department of Yoga Science,
University of Patanjali,
Room No.508
Haridwar – 249405, Uttarakhand, India.
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7310579094 |
| Fax |
|
| Email |
ranamamta641@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRajesh Mishra |
| Designation |
Assistant Professor in Dravyagun Vigyan |
| Affiliation |
evam Anusandhan Sansthan |
| Address |
Dept.of Dravyagun Vigyan, Patanajli Bhartiya Ayurvigyan evam Anusandhan Sansthan
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7895979176 |
| Fax |
|
| Email |
rajesh.mishra@prft.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DrRajesh Mishra |
| Designation |
Assistant Professor in Dravyagun Vigyan |
| Affiliation |
evam Anusandhan Sansthan |
| Address |
Dept.of Dravyagun Vigyan, Patanajli Bhartiya Ayurvigyan evam Anusandhan Sansthan
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7895979176 |
| Fax |
|
| Email |
rajesh.mishra@prft.co.in |
|
|
Source of Monetary or Material Support
|
| Patanjali Ayurved Hospital,
Patanjali Yogpeeth phase I,
Delhi Haridwar National Highway,
Haridwar 249405, Uttarakhand, India.
|
|
|
Primary Sponsor
|
| Name |
Km Mamta |
| Address |
Department of Yoga Science,
University of Patanjali,
Haridwar 249405, Uttarakhand, India. |
| Type of Sponsor |
Other [Self-Funded ] |
|
|
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 Monika Sharma |
Patanjali Ayurved Hospital |
Department of Yoga Science,
University of Patanjali,
Haridwar 249405, Uttarakhand, India.
Hardwar
UTTARANCHAL |
9412937920
monikayog@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, University of Patanjali, Haridwar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A – Yoga Module for Obesity; Group B – Aconitum heterophyllum Wall. Ex Royle (processed root powder) |
Group A will practice a structured yoga program for 60 minutes, 6 days/week for 90 days. Group B will take a standardized dose of processed Aconitum heterophyllum root powder orally once daily for 90 days. |
| Comparator Agent |
Group C – Control Group |
Group-C will not receive any intervention. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Age-18 to 50 years
With BMI greater than 24.5
Non yoga practioners
Commitment to follow up intervention
General diet recommendation
|
|
| ExclusionCriteria |
| Details |
Regular yoga practitioners
Alcohol or substance abuse
Pregnancy or lactation
Severe psychiatric disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Body Weight, BMI, Waist Circumference, and Waist-Hip Ratio from baseline week 0 to 12. |
Baseline (week 0): Before starting the intervention
End of Study(week 12): After completion of the intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Psychological & quality of life parameters: Changes in Depression, Anxiety, & Stress measured by DASS-21, eating behavior patterns measured by EAT-26, & obesity-related quality of life measured by WHOQOL. |
Baseline (Week 0): Before starting the intervention
End of Study (Week 12): After completion of the intervention. |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
15/09/2025 |
| 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="0"
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 randomized controlled trial aims to evaluate the efficacy of a structured Yoga module and standardized processed Aconitum heterophyllum (Atis) root powder in the management of Sthaulya (overweight) with comorbid psychological conditions. A total of 120 participants aged 18 to 50 years with BMI 25 and above will be enrolled and randomly divided into three groups. Group A will receive Yoga intervention combined with standardized processed Aconitum heterophyllum root powder, Group B will receive Yoga intervention only, and Group C will serve as control with no intervention. The duration of the study will be 90 days. The primary outcomes will be changes in weight, body mass index, waist circumference, and waist hip ratio, along with psychological parameters measured by DASS 21, IWQOL, and EAT 26. Assessments will be carried out at baseline and after 90 days. The study is designed to provide scientific evidence on the role of Yoga and standardized Ayurvedic medicine in obesity management and associated psychological well being. |