| CTRI Number |
CTRI/2022/03/040807 [Registered on: 04/03/2022] Trial Registered Prospectively |
| Last Modified On: |
08/03/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Yoga for Osteoarthritis of Knee |
|
Scientific Title of Study
|
To Study the Effect of Yoga Therapy in reducing pain, improving walking time and quality of life in the management of OA Knee- A prospective randomised control study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sujatha George |
| Designation |
Consultant Physician |
| Affiliation |
Yoga & Naturopathy OPD,(CCRYN) Safdurjung Hospital |
| Address |
Ansari Nagar East, near to AIIMS Metro Station, New Delhi, Delhi
South
DELHI
110029
India |
| Phone |
8076932227 |
| Fax |
|
| Email |
suja1962@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujatha George |
| Designation |
Consultant Physician |
| Affiliation |
Yoga & Naturopathy OPD,(CCRYN) Safdurjung Hospital |
| Address |
Ansari Nagar East, near to AIIMS Metro Station, New Delhi, Delhi
South
DELHI
110029
India |
| Phone |
8076932227 |
| Fax |
|
| Email |
suja1962@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sujatha George |
| Designation |
Consultant Physician |
| Affiliation |
Yoga & Naturopathy OPD,(CCRYN) Safdurjung Hospital |
| Address |
Ansari Nagar East, near to AIIMS Metro Station, New Delhi, Delhi
South
DELHI
110029
India |
| Phone |
8076932227 |
| Fax |
|
| Email |
suja1962@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Yoga & Naturopathy, Ministry of AYUSH |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Yoga and Naturopathy Ministry of AYUSH |
| Address |
61-65, opp. D Block, Janakpuri Institutional Area, Janakpuri, New Delhi, Delhi 110058 |
| Type of Sponsor |
Government funding agency |
|
|
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 Lovneesh G Krishna |
Safdurjung Hospital Ortho OPD |
Orthopedic OPD Sfdurjung Hopital, New Delhi
New Delhi
DELHI |
9810097804
loveneesh_krishna@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Vardhaman Mahavir Medical College & Safdarjung Hospital, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Physical exercise |
Physiotherapy protocol for OA knee (3months) |
| Intervention |
Yoga Therapy |
Yogic practices specific to OA knee ( 3 months) |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed as having OA Knee(one or both joints) satisfying the ACR Guidelines.
Age above 35 -70 yr.
on/off NSAIDs
Kellgren-Lawrence grade- 1 and 2 on X-ray
|
|
| ExclusionCriteria |
| Details |
Rheumatoid, arthritis, fibromyalgia, recurrent or active pseudo-gout, cancer or other serious medical condition
History of Recent trauma to the lower limbs
History of stroke or paraplegia or hemiparesis or hemiplegia
History of ligament injury/ tear in any knee joint
Oral steroids within the last four weeks
Intra Auricular injection _the last 4 to 6 months
Undergone Arthroscopy of knee
Valgus deformity-grade 3 and above
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) In the reduction of Pain during activities
2) Improvement in daily physical activities and Quality of Life.
|
Every week, upto 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in daily physical activities and Quality of Life.
|
Every week, upto 3 months |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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)
|
15/03/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study includes both yoga intervention as well as physiotherapy intervention such as transcutaneous electrical stimulation and ultrasound treatment which makes it difficult to ascertain the effect of yoga alone. Hence the present study is planned to assess the effect of yoga therapy alone in the management of pain, walking time, and quality of life compared to exercise regimen among the subjects suffering from OA Knee. |