| CTRI Number |
CTRI/2021/04/032633 [Registered on: 07/04/2021] Trial Registered Prospectively |
| Last Modified On: |
16/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Other |
|
Public Title of Study
|
Yoga is useful in multiple sclerosis relapse and quality of life |
|
Scientific Title of Study
|
Efficacy of yoga on frequency of multiple sclerosis relapse and quality of life. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SREEDHAR PALUKURU |
| Designation |
PhD Scholar |
| Affiliation |
Swami Vivekananda Yoga Anusandhana Samsthana SVYASA |
| Address |
Swami Vivekananda Yoga Anusandhana Samsthana (SVYASA)
Prashanthi Kutiram Department of Yoga and Life Sciences Kallu Ballu Post
Anekal Taluq Jigani Bangalore
Prashanthi Kutiram Department of Yoga and Life Sciences Kallu Ballu Post
Anekal Taluq Jigani Bangalore 560105
Bangalore
KARNATAKA
560105
India |
| Phone |
9632648161 |
| Fax |
|
| Email |
sreedharpalukuru@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Netravathi M |
| Designation |
Additional Professor |
| Affiliation |
National Institute of Mental Health and Neurosciences (NIMHANS) |
| Address |
Department of Neurology,
National Institute of Mental Health and Neurosciences (NIMHANS),
Bangalore
Bangalore
KARNATAKA
560029
India |
| Phone |
9880106662 |
| Fax |
|
| Email |
netravathi.m@nimhans.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Suchitra S Patil |
| Designation |
Assistant Professor |
| Affiliation |
Swami Vivekananda Yoga Anusandhana Samsthana (SVYASA) |
| Address |
Swami Vivekananda Yoga Anusandhana Samsthana (SVYASA)
Prashanthi Kutiram Department of Yoga and Life Sciences Kallu Ballu Post
Anekal Taluq Jigani Bangalore
Bangalore
KARNATAKA
560105
India |
| Phone |
9449664969 |
| Fax |
|
| Email |
suchitra@svyasa.edu.in |
|
|
Source of Monetary or Material Support
|
| No source of monetary or material support. Study part of Doctoral thesis submitted to Swami Vivekananda Yoga Anusandhana Samsthana (S-VYASA), Bangalore, India. |
|
|
Primary Sponsor
|
| Name |
Sreedhar Palukuru |
| Address |
382 2nd main 3rd cross south avenue layout gottigere off bannerghatta main road bangalore-560083 |
| Type of Sponsor |
Other [Self Sponsored] |
|
|
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 |
| Sreedhar Palukuru |
National Institute of Mental Health and Neurosciences (NIMHANS) |
Department of Neurology,
NIMHANS, Hosur
Road,
Bangalore - 560029
Bangalore
KARNATAKA |
9632648161
sreedharpalukuru@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Human Ethics Committee for Research in AYUSH and integrative Medicine |
Approved |
| Institutional Ethics 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 Care as usual |
Standard hospital treatment for 12 months of follow up. |
| Intervention |
Yoga |
2 hours daily, 12 sessions per month for 12 months with follow up for 12 months. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
a) Definite diagnosis of RRMS by neurologist.
b) Male and Female in the age group of 25 to 50 years
c) Subjects with history of MS relapse
d) Willingness to participate in the study
e) Subjects presently without relapse
f) Subjects consenting for yoga practice for 1 year
|
|
| ExclusionCriteria |
| Details |
a) Person with Cardiovascular diseases
b) Person with musculoskeletal (fracture, advanced stage of osteoporosis, osteoarthritis etc.) disorders
c) Person with disease that may impede exercise or practice of yoga.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
• To assess the effect of yoga practice for 12 months period in RRMS participants on Quality of Life (QOL) through SF-36.
• To assess the effect of Yoga practice for 12 months period in RRMS participants on frequency of relapses in a year.
|
Quality of life assessed at Baseline, 3rd month, 6th month & 12th month.
Frequency of relapse assessed at Baseline, 3rd month, 6th month & 12th month. |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Neuropsychological tests (Color Trails 1 &2, Verbal working memory, Visual working memory, Verbal Learning and memory (AVLT), Visual Learning and memory (CFT), Spielberg’s State Trait anxiety inventory, Patient’s Health Questionnaire for depression.
•Disability through EDSS.
Adding MRI (Magentic Resonance Imaging) of brain for the study. |
Neuropsychological tests at Baseline & 12th month.
EDSS at Baseline, 3rd month, 6th month & 12 month.
MRI for the subject will be as per NIMHANS routine clinical practice for Multiple Sclerosis(MS) subjects. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
15/04/2021 |
| 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="2"
Months="4"
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 adopted convenient
sampling (open label) method to asses the effect of yoga practice for 12 months
period in relapsed remitting multiple sclerosis (RRMS) patients on quality of
life (QOL) through SF-36 & on frequency of relapse in a year, on cognition
through Neuropsychological tests, on disability measured by EDSS. The yoga
practice is planned for those who provide their consent to be part of the
study, 12 sessions per month for 12 months. Based on the patient’s convenience
off-line and on-line yoga classes are planned for 12 months. |