| CTRI Number |
CTRI/2025/10/095624 [Registered on: 06/10/2025] Trial Registered Prospectively |
| Last Modified On: |
04/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Yoga & Naturopathy
Diagnostic
Preventive
Screening |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Yoga Therapy on Patients with Knee Osteoarthritis (Janusandhigata Vata) |
|
Scientific Title of Study
|
To Study the Effect of Yoga as an Add-on Therapy in the management of Knee Osteoarthritis (Janusandhigata Vata) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kalpana Rawat |
| Designation |
PhD Scholar |
| Affiliation |
Institute of Medical Sciences Banaras Hindu Uninversity |
| Address |
Department of Kayachikitsa Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9140969280 |
| Fax |
|
| Email |
kalpana0934@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Sunanda Ramkrishna Pedhekar |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences Banaras Hindu University |
| Address |
Department of Kayachikitsa Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9423241800 |
| Fax |
|
| Email |
drspedhekar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kalpana Rawat |
| Designation |
PhD Scholar |
| Affiliation |
Institute of Medical Sciences Banaras Hindu University |
| Address |
Department of Kayachikitsa Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9140969280 |
| Fax |
|
| Email |
kalpana0934@gmail.com |
|
|
Source of Monetary or Material Support
|
| Faculty of Ayurveda institute of Medical Sciences banaras Hindu University Varanasi UP |
| UGC NET JRF FELLOWSHIP |
|
|
Primary Sponsor
|
| Name |
Department of Kayachikitsa |
| Address |
Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi up India 221005 |
| Type of Sponsor |
Government 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 |
| Kalpana Rawat |
Sir SunderLal Hospital |
Room No. 21 and 22 Ground Floor
Kayachikitsa OPD Indian Medicine Wing
Sir SunderLal Hospital Institute of Medical Sciences Banaras Hindu University Varanasi
Varanasi
UTTAR PRADESH |
09140969280
kalpana0934@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, (2) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group
Abhadi Guggul only |
only Abhadi Guggul will be given for 90 days. 3gms/day in divided doses(TID) after food with warm water
Yoga will not be given in this group |
| Intervention |
Experimental Group
Yoga Therapy with Abhadi Guggul |
30 min Yogic Intervention including Sukshma Vyayama & Pranayama by relaxation will be given daily for 90 days |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age criteria between 35 and 70 years with knee osteoarthritis will be included
Diagnosed patients with classical symptoms of knee osteoarthritis of both sex male & female will be included
Diagnosed patients with classical symptoms of knee osteoarthritis irrespective of religion caste & socioeconomic status will be included
Diagnosed patients with classical symptoms of knee osteoarthritis will be included from Sir SunderLal Hospital IMS BHU.
Patients who are willing to participate in the study |
|
| ExclusionCriteria |
| Details |
Age below 35 years and above 70 years
Pregnant and lactating mother
Patients with secondary arthritis
Those having severe bone and joint deformity
Suffering from chronic hepatic renal and cardiac disease
Patients who are obese BMI more than 30 |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Relief in sign and symptoms of the disease knee osteoarthritis by abhadi guggul with and without yoga therapy
signs and symtoms are as follows
1 Shoola
2 Shotha
3 Stambh
4 Pidanasahava
5 Sphutana
6 Akunchana prasarana vedana |
90 days study with follow up of every 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment of Objective and Subjective criteria by Goniometer and VAS scale
Effect of yoga on knee osteoarthritis will scientifically approve and will made useful in the view of economy |
90 days study with follow up of every 30 days |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
16/10/2025 |
| 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 Applicable |
| 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 is an Interventional Study on Patients with Knee osteoarthritis. 150 diagnosed patients with classical symptoms of knee osteoarthritis will be selected by the randomization method of lottery. These 150 patients will be divided into two different groups respectively Group A Experimental Group and Group B Control Group. 75 Patients in group A and 75 in group B. A total duration is 90 days with 3 follow-ups every 30 days. Data will be collected from OPD and IPD of Indian Medicine System Sir SunderLal Hospital IMS BHU Varanasi UP. Intervention of Group A will be Yoga Therapy with Abhadi Guggul and Intervention of Group B will be Abhadi Guggul only. Yoga Therapy will not be given in Group B. The purpose of this study is to compare the effect of Abhadi Guggul with and without Yoga Therapy on patients with knee osteoarthritis. |