| CTRI Number |
CTRI/2024/10/075711 [Registered on: 23/10/2024] Trial Registered Prospectively |
| Last Modified On: |
12/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To find out effectiveness of Sudarshan kriya breathing exercise on patients with paralysis |
|
Scientific Title of Study
|
Additional Effect of Sudarshan Kriya Yogic Breathing on Memory, Attention and Quality of Life in Recovering Stroke Subjects – Randomized Control Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jotishko Biswas |
| Designation |
MPT student |
| Affiliation |
Parul Institue of Physiotherapy |
| Address |
room no.309 3rd floor Parul institute of Physiotherapy (PIPT) Parul University Limda Waghodia Vadodara Gujrat
391760 India
Vadodara
GUJARAT
391760
India |
| Phone |
8141193110 |
| Fax |
|
| Email |
jotishko.biswas@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Joyal Tejpal |
| Designation |
Assistant Professor |
| Affiliation |
Parul Institue of Physiotherapy |
| Address |
room no.309 3rd floor Parul institute of Physiotherapy (PIPT) Parul University Limda Waghodia Vadodara Gujrat
391760 India
Vadodara
GUJARAT
391760
India |
| Phone |
9909981454 |
| Fax |
|
| Email |
joyaltejpal25384@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Joyal tejpal |
| Designation |
Assistant Professor |
| Affiliation |
Parul Institue of Physiotherapy |
| Address |
room no.309 3rd floor Parul institute of Physiotherapy (PIPT) Parul University Limda Waghodia Vadodara Gujrat
391760 India
Vadodara
GUJARAT
391760
India |
| Phone |
9909981454 |
| Fax |
|
| Email |
joyaltejpal25384@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| room no.309 3rd floor Parul institute of Physiotherapy (PIPT) Parul University Limda Waghodia Vadodara Gujrat
391760 India |
|
|
Primary Sponsor
|
| Name |
Jotishko Biswas |
| Address |
room no. 201 3rd floor parul institute of physiotherapy , parul university post. limbda, waghodia, Vadodara
Gujarat, India pincode:391760 |
| 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 |
| DRJoyal Tejpal |
Parul sevasharam hospital |
Room no 232 Neuro rehabilitation center neuro opd
Vadodara
GUJARAT |
9909981454
joyel.tejpal25384@paruluniversity.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul University Instituitional Ethics Committe For Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G819||Hemiplegia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional physiotherapy |
6 days in a week for 4 weeks. |
| Intervention |
Sudarshan Kriya Yogic Breathing |
6 days in a week for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient with sub-acute stroke
2. Involving all the 3 cortical vascular territories.
3. Age group: 30 to 50 years
4. No visual, auditory and perception disorders
5. Able to understand command
6. Willing to sign the consent form
|
|
| ExclusionCriteria |
| Details |
Any sensory impairment present.
2. Internal ear infection
3. Any unhealed ulcers and painful wounds .
4. Presence of any deformities or adapted posture due to stroke
5. Any recent fracture or surgery
6. Patient having delirium, confusion or other severe consciousness problem.
7. No disease other than stroke that influence patients functional capacity
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Digit span test
Mini mental scale |
4 weeks for 6 days / week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Stroke Specific Quality Of Life |
4 weeks for 6 days/week |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
12/11/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
To find out the impact of Sudarshan kriya breathing technique on memory, attention and quality of life in stroke individuals. It is a long breathing exercise which help to improve quality of life. It works by increasing oxygen level in the cell to reduce stress and remove toxins outside of body it improves overall condition of the patient so my need of study to establish effect of Sudarshan kriya yoga on patients having stroke. |