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CTRI Number  CTRI/2021/07/034788 [Registered on: 12/07/2021] Trial Registered Prospectively
Last Modified On: 12/07/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Single Arm Study 
Public Title of Study   Yoga for multiple sclerosis 
Scientific Title of Study   Development and feasibility of integrated yoga therapy module for patients suffering with Multiple sclerosis. A pilot study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrNetravathi M 
Designation  Additional Professor 
Affiliation  NIMHANS 
Address  Department of Neurology First floor National Institute of Mental Health and Neuro Sciences An Institute of National Importance Hosur road Bangalore INDIA

Bangalore
KARNATAKA
560029
India 
Phone    
Fax    
Email  sundernetra@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Hemant Bhargav 
Designation  Assistant Professor 
Affiliation  NIMHANS 
Address  Department of Integrative Medicine First floor National Institute of Mental Health and Neuro Sciences An Institute of National Importance Hosur road Bangalore INDIA

Bangalore
KARNATAKA
560029
India 
Phone  08026995983  
Fax    
Email  drbhargav.nimhans@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Usha Rani MR 
Designation  Research Officer 
Affiliation  NIMHANS 
Address  Department of Integrative Medicine First floor National Institute of Mental Health and Neuro Sciences An Institute of National Importance Hosur road Bangalore INDIA

Bangalore
KARNATAKA
560029
India 
Phone  08026995730  
Fax    
Email  ushaayog@gmail.com  
 
Source of Monetary or Material Support  
Central council for Research in Yoga and Naturopathy New Delhi 
 
Primary Sponsor  
Name  CCRYN 
Address  61-65 Janakpuri Institutional Area Janakpuri New Delhi 110058 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Netravathi  NIMHANS  Department of Neurology First floor Hosur road Bangalore
Bangalore
KARNATAKA 		 08026995485
08026995485
sundernetra@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human ethics committee for Research in Ayush and Integrative Medicine  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G30-G32||Other degenerative diseases of the nervous system. Ayurveda Condition: MS,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not applicable  Not applicable 
Intervention  yoga therapy  The therapy will involve different mind-body components including loosening exercises, breathing practices, asanas, pranayama, bandhas (locks), relaxation and yogic counselling for MS. The therapy module will be of 1 hour duration. To be taught for 5 days a week for 2 weeks (10 supervised sessions). First session will be under direct in-person supervision after that subjects will be taught the same through tele-mode. After initial 10 sessions subjects will continue home practice for another 2 weeks using recorded videos and practice list. So total duration of intervention is 4 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  A diagnosis of CDMS clinically defined multiple sclerosis using revised McDonald criteria 2010 2017 revision).
Relapsing-remitting multiple sclerosis
Minimum education with the ability to read and write
Consent to take part in the study
EDSS Expanded Disability Status Scale score between 0 and 6
On stable medication for at least 6 weeks
 
 
ExclusionCriteria 
Details  Any condition which the investigator feels that the patient is unsuitable.
Patients with Progressive course which resulted in early disability.
Patients of Expanded Disability Status Scale (EDSS) score 7 and above
Patients with Mini-Mental State Examination (MMSE) score more than or equal to 27.
Women with h/o of menorrhagia Dysfunctional uterine bleeding.
Neurological disorders (Epilepsy and Parkinsonism) and other neuro-degenerative disorders with MS complex.
Patients with substance dependence (except nicotine).
Pregnant and lactating women or women planning for pregnancy.
Patients with uncontrolled Type 2 Diabetes mellitus (FBS >126 mg/dl PPBS > 200 mg/dl.
Subjects on β-blockers thiazide diuretics corticosteroids HRT.
Subjects with Uncontrolled Hypertension (with or without medication).
Patients with concurrent Hepatic Dysfunction (defined as AST and/or ALT > 2 times of the upper normal limit) or Renal Dysfunction (defined as S.Creatinine > greater than ULL) uncontrolled Pulmonary Dysfunction (asthmatic and COPD subjects).
Patients with evidence of malignancy.
Patients with recent H/O fever.
Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis Psycho-Neuroendocrinal disorders etc.)
Patients who have completed participation in any other clinical trial during the past six (06) months.
Practice of a structured yoga module in the past 3 months (three or more times per week) prior to the study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To develop an Integrated Yoga Module for patients diagnosed with mild to moderate symptoms of relapsing remitting multiple sclerosis and who is ambulatory.
To study its feasibility and acceptability in this population.
 		 Baseline,10 days,1 month
 
 
Secondary Outcome  
Outcome  TimePoints 
Not applicable  NA 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   14/07/2021 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Multiple sclerosis (MS) is the most common autoimmune inflammatory demyelinating disease of the central nervous system leading to severe disability. A wide range of symptoms can cause significant functional limitations leading to poor quality of life. Pharmacological treatments are symptomatic and delay the progression of disability. Their role is limited in reversing mobility disability or restoring ambulatory function in persons with MS. In recent years more individuals with MS have been pursuing complementary and alternative medicine (CAM) to manage symptoms of the disease and Yoga is the most popular one in use. Studies have suggested yoga to be a holistic, cost-effective safe and potential intervention in the management of MS. However, there is no clear guideline or specific yoga module designed for MS in the literature. In this context, we intend to develop a yoga module that is safe and effective for MS and study its feasibility in this population.

 
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