| CTRI Number |
CTRI/2020/12/029865 [Registered on: 16/12/2020] Trial Registered Prospectively |
| Last Modified On: |
15/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of yoga on ALS patients. |
|
Scientific Title of Study
|
Randomized control trial to study the effect of yoga on neurological function, Quality of life, Biomarker and Imaging of ALS patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhishek Pathak |
| Designation |
Associate professor |
| Affiliation |
Institute of Medical Sciences |
| Address |
Department of Neurology,
Institute of Medical Sciences,
Banaras Hindu University.
Department of Neurology,
Institute of Medical Sciences,
Banaras Hindu University.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8948512666 |
| Fax |
|
| Email |
abhishekpathakaiims@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhishek Pathak |
| Designation |
Associate professor |
| Affiliation |
Institute of Medical Sciences |
| Address |
Department of Neurology,
Institute of Medical Sciences,
Banaras Hindu University.
Department of Neurology,
Institute of Medical Sciences,
Banaras Hindu University.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8948512666 |
| Fax |
|
| Email |
abhishekpathakaiims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priyanka Gautam |
| Designation |
Research Fellow |
| Affiliation |
Institute of Medical Sciences |
| Address |
Department of Neurology,
Institute of Medical Sciences,
Banaras Hindu University.
Department of Neurology,
Institute of Medical Sciences,
Banaras Hindu University.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9664091851 |
| Fax |
|
| Email |
priyapreetgautam123@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of Science and Technology |
| Address |
Technology Bhavan, New Mehrauli Road, Block C, Qutub Institutional Area, New Delhi, Delhi 110016 |
| 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 |
| Abhishek Pathak |
Department of neurology |
Neurology Lab, Institute of Medical Sciences, Banaras Hindu University
Varanasi
UTTAR PRADESH |
8948512666
abhishekpathakaiims@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee, IMS, BHU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G122||Motor neuron disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Non-yoga or control |
Not doing yoga |
| Intervention |
Yoga |
Iyengar yoga for 12 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All consecutive ALS patients (diagnosed as per Awaji Shima Criteria 2008, definite, probable and possible) visiting the Neurology OPD or admitted in Neurology ward will be included in the study.
Patient consenting for the study.
|
|
| ExclusionCriteria |
| Details |
Patients unable to perform the yoga and meditation exercises.
Patients not consenting to the study.
ALS with dementia (FTD-ALS)
Previous history of any dementia or any strokes in the past. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Motor power |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Any effect on Neurofilament light Chain |
6 months |
| Any effect on Quality of Life |
6 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
24/12/2020 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Amyotrophic lateral Sclerosis is a neurodegenerative disease of motor neurons and has poor therapeutic options with relentless progressive clinical course with severe disability and eventually mortality. Iyenger Yoga has been shown to have some effect on cramps in these group of patients. Preliminary data from our ALS registry patients have shown that few patients who are advised for Yoga and meditation do relatively well with motor, quality of life scales and cramps and fasciculations. This present trial would have a detailed and extensive study, to assess the effect of Yoga in ALS patients on neurological functions, quality of life, imaging and studied biomarker. ALS patients would be randomized by computer generated method to group patients into yoga and non-yoga group and would be assessed to compare the outcome at regular intervals of 0 and 6 months.Neurofilament light chain from serum of yoga and control group patients along with their DTI brain sequences will be evaluated at 0 and 06 months time interval. The results would be independently assessed by an blinded assessor at the end of the study. |