| CTRI Number |
CTRI/2025/06/088934 [Registered on: 16/06/2025] Trial Registered Prospectively |
| Last Modified On: |
14/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Positive effects of yoga on osteoarthritis in women |
|
Scientific Title of Study
|
Effects of yogic practices on pain, quality of sleep, joint range of motion on osteoarthritis of knee joint of middle aged women |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhargavi Mannava |
| Designation |
scholar |
| Affiliation |
Meenakshi Academy of Higher Education and Research |
| Address |
Meenakshi Academy of higher education and research
Department faculty yoga science and therapy division 3rd floor room no 303 no 12 vembuliamman koil street west kk nagar chennai
Chennai
TAMIL NADU
600078
India |
| Phone |
8527964910 |
| Fax |
|
| Email |
imcoolsudha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G Raghuram |
| Designation |
Associate Professor |
| Affiliation |
Meenakshi Academy of Higher Education and Research |
| Address |
Meenakshi Academy of Higher Education and Research
Department Faculty of Yoga Science and Therapy Division 3rd floor Room No 303 No 12 Vembuliamman Koil Street West
KK Nagar
chennai
India
Chennai
TAMIL NADU
600078
India |
| Phone |
9840691849 |
| Fax |
|
| Email |
drraghu-yoga@maher.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Bhargavi Mannava |
| Designation |
Scholar |
| Affiliation |
Meenakshi Academy of Higher Education and Research |
| Address |
Meenakshi Academy of Higher Education and Research
Department Faculty of Yoga Science and Therapy Division 3 rd floor Room no 303 No 12 Vembuliamman Koil Street West KK Nagar Chennai
Chennai
TAMIL NADU
600078
India |
| Phone |
8527964910 |
| Fax |
|
| Email |
imcoolsudha@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
MEENAKSHI ACADAMY OF HIGHER EDUCATION AND RESEARCH |
| Address |
MAHER,No,12 Vembuliamman Koil Street, West K.K.Nagar, Chennai-600078 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Bhargavi Mannava |
ECHS |
2-12-1, 11, 1st ln, Syamala Nagar, Guntur
Guntur
ANDHRA PRADESH |
8527964910
imcoolsudha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee Meenakshi Academy of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Osteoarthritis |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
yoga |
Yoga Asanas, Pranayama and Mudra |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
The study has limited to middle aged women.
The age of subjects confined from 35 to 55 years only.
The independent variables are selected chair suryanamaskar yogasana pranayama mudra meditation.
The subjects are knee osteoarthritis.
Investigation has not taken in the account of previous life style pattern of the subject.
The participants will be assessed if suitable for practising yogic practices based on physical preliminary exam. |
|
| ExclusionCriteria |
| Details |
The factors like climatic conditions,environmental and social-economical status are not to be taken into connsederation.
Certain factors like life style, food habits, body alignment,personal way of life and motivational factors are not to be taken into consideration for this study.
The day to day routines would not be controlled for this study.
Chronic knee osteoarthritis patients.
Those do not give consent form. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Physiological : pain (visual analogue scale)
stiffness in joints (goniometer)
BP (omron Digital)
Radiological:X-Ray |
Fequency: 5 days a week
Duration : 3months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Anthropometric
Psychological Variables (Depression, Anxiety, Stress Questionnaire) |
Frequency: 5 days a week
Duration: 3 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
25/06/2025 |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [imcoolsudha@gmail.com].
- For how long will this data be available start date provided 30-06-2025 and end date provided 30-06-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
This study would be conducted for the partial fulfilment off the PhD study at Meenakshi Academy of Higher Education and Research (Deemed to be University), Chennai. This study explores yoga’s intervention as a complementary therapy for middle aged women with knee osteoarthritis. Comparing yoga intervention with a controlled group,it analyses effects of knee joints n mental well-being.
The research aims to integrate yoga into knee osteoarthritis management plans for for improved health and well being in middle aged women. The study delves into the effectiveness of yoga as complementary therapy for middle aged women suffering from knee
osteoarthrites. Experimental group of Yogis will be immersed in daily practice of chair surya namaskar , Asanas, Mudras, Meditation and pranayama for 3 months. The controlled group will be engaging in active rest over the same period. Aim is to uncover the impact of yoga on various aspects of life for these middle aged women, to reduce the knee pain n stiffness. |