| CTRI Number |
CTRI/2024/09/074431 [Registered on: 26/09/2024] Trial Registered Prospectively |
| Last Modified On: |
06/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effect of Yoga on Multiple Sclerosis Patients |
|
Scientific Title of Study
|
Effect of Integrated Yoga Module on Patients with Relapsing Remitting Multiple Sclerosis |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bharti Patel |
| Designation |
Ph.D. Student |
| Affiliation |
Gujarat Vidyapith |
| Address |
Gujarat Vdyapith, Yogvidya department, Ashram Road, Ahmedabad.
Ahmadabad
GUJARAT
380009
India |
| Phone |
9377277880 |
| Fax |
|
| Email |
sgmbharti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Biman Bihari Paul |
| Designation |
Professor and Guide |
| Affiliation |
Gujarat Vidyapith |
| Address |
Gujarat Vdyapith, Yogvidya department, Ashram Road, Ahmedabad.
Ahmadabad
GUJARAT
380009
India |
| Phone |
9427622254 |
| Fax |
|
| Email |
biman.yoga@gujaratvidyapith.org |
|
Details of Contact Person
Public Query
|
| Name |
Bharti Patel |
| Designation |
Ph.D. Student |
| Affiliation |
Gujarat Vidyapith |
| Address |
Gujarat Vdyapith, Yogvidya department, Ashram Road, Ahmedabad.
Ahmadabad
GUJARAT
380009
India |
| Phone |
9377277880 |
| Fax |
|
| Email |
sgmbharti@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yoga Department, Gujarat vidyapith, Ashram Road, Nr. Income Tax Office, Ahmedabad-380009, Gujarat, India. |
|
|
Primary Sponsor
|
| Name |
Bharti Patel |
| Address |
14, Samarpan Avenue, Opp. Rambaug Police Station, Rambaug, Maninagar, Ahmedabad-380008. |
| Type of Sponsor |
Other [Self ] |
|
|
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 Biman Paul |
Gujarat Vidyapith |
Gujarat Vidyapith, Yogvidya Department, Ashram Road, Ahmedabad-380009.
Ahmadabad
GUJARAT |
9427622254
biman.yoga@gujaratvidyapith.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G35||Multiple sclerosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard usual care |
RRMS patients on standard usual care but who would not receive the Yoga therapy.
|
| Intervention |
Yoga |
•Intervention period 12 weeks, frequency 5 sessions per week, session duration 60 minutes
(Total 60 sessions).
•Integrated Yoga Module (by Palukuru et al., 2021) will be used as complimentary in addition
to conventional medicine. Yoga Module comprises Loosening exercises (Sukshma vyayamas),
Asanas, breathing practices (Pranayama), Bandhas and mudras, relaxation, and meditation.
•Yogic counseling on daily activity, diet, rest, sleep, workout for stress and weight
management, abstinence from addictive substance...etc.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
64.00 Year(s) |
| Gender |
Both |
| Details |
•Diagnosed RRMS by Neurologist and in remission.
•Written informed concent. |
|
| ExclusionCriteria |
| Details |
•Any condition which the investigator feels that
the patient is unsuitable.
•SPMS, PPMS, PRMS.
•Pregnant and lactating women or women planning
for pregnancy.
•Lever and kidney failure.
•Suffering from lung disease.
•Suffering from epilepsy or parkinsonism.
•Patients with profound cognitive impairment.
•Psychiatric or cardiac disorder.
•Participation in similar intervention in last 3
months.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the effects of Integrated Yoga Module on Balance, fatigue, Anxiety and Depression in RRMS patients using
1. Balance - Berg Balance Scale (BBS).
2. Fatigue – Fatigue Severity Scale (FSS)
3. Anxiety and Depression – Hospital Anxiety and Depression Scale (HADS).
|
Baseline, 6 weeks and 12 weeks
post-intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Physical pain and Quality of Life – Questionnaire MSQoL-54. |
Baseline, 6 weeks and 12 weeks
post-intervention |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/11/2024 |
| Date of Study Completion (India) |
31/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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)
|
Need for the study in India Advancement in diagnostic tools and disease awareness, MS increasingly diagnosed in India. MS not only affects the patient but also affects the patient’s family both mentally and economically. Yoga interventions used in the previous studies have been heterogenous. Except Vasudevan et al., 2021 (location Chennai) no other experimental published data is available from our country on the study of yoga in MS. There is need for region specific studies across various states in India, as a diverse geographic and demographic characteristic of Indian population may impact the effectiveness of yoga Interventions for MS patients, requiring tailored approaches to address these factors. Therefore, the aim of the study is to make preliminary investigation to rule the feasibility and reliability of effectiveness of integrated yoga module (By Palukuru et al., 2021) for practice in RRMS patient for MS symptoms management and improving quality of life. Note: The DASS-21 (Depression Anxiety and Stress-21) scale was used instead of HADS. |