| CTRI Number |
CTRI/2024/03/063606 [Registered on: 05/03/2024] Trial Registered Prospectively |
| Last Modified On: |
28/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Association of treatment satisfaction with treatment outcomes of yoga and allied therapies |
|
Scientific Title of Study
|
Treatment satisfaction and outcome following a week of yoga and allied Therapies |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shirley Telles |
| Designation |
Director of Research |
| Affiliation |
Patanjali Research Foundation (Trust) |
| Address |
Department of Yoga Research, 2nd floor, Sadbhawana Building,
Patanjali Research Foundation (Trust), Patanjali Yogpeeth Phase 1,
Bahadrabad, Hardwar UTTARANCHAL 249405 India
Hardwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
09897963254 |
| Fax |
09896973254 |
| Email |
office@prft.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shirley Telles |
| Designation |
Director of Research |
| Affiliation |
Patanjali Research Foundation (Trust) |
| Address |
Department of Yoga Research, 2nd floor, Sadbhawana Building,
Patanjali Research Foundation (Trust), Patanjali Yogpeeth Phase 1,
Bahadrabad, Hardwar UTTARANCHAL 249405 India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
09897963254 |
| Fax |
09896973254 |
| Email |
office@prft.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shirley Telles |
| Designation |
Director of Research |
| Affiliation |
Patanjali Research Foundation (Trust) |
| Address |
Department of Yoga Research, 2nd floor, Sadbhawana Building,
Patanjali Research Foundation (Trust), Patanjali Yogpeeth Phase 1,
Bahadrabad, Hardwar UTTARANCHAL 249405 India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
09897963254 |
| Fax |
09896973254 |
| Email |
office@prft.co.in |
|
|
Source of Monetary or Material Support
|
| Patanjali Research Foundation (Trust), Patanjali Yogpeeth Phase 1, Bahadrabad, Haridwar,
Uttrakhand, India, 249405 |
|
|
Primary Sponsor
|
| Name |
Patanjali Research Foundation trust |
| Address |
Department of Yoga Research, 2nd floor, Sadbhawana Building,
Patanjali Research Foundation (Trust), Patanjali Yogpeeth Phase 1,
Bahadrabad, Hardwar UTTARANCHAL 249405 India |
| Type of Sponsor |
Research institution |
|
|
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 Shirley Telles |
Wellness Center |
Wellness Center, Block 5, Patanjali Yogapeeth Phase 2
Hardwar
UTTARANCHAL
Hardwar
UTTARANCHAL |
9897963254
office@patanjali.res.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Department of Yoga Research, Patanjali Research Foundation |
Approved |
| Institutional Ethics Committee of Department of Yoga Research, Patanjali Research Foundation (Trust) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, (2) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. Age-18 years and above.
2. Patients with non communicable disease attending a yoga therapy for the management of the illness counted for 7 days. |
|
| ExclusionCriteria |
| Details |
1. Patients who will not complete the questionnaire satisfactorily will be excluded.
2. Patients who will not complete 7 days of yoga therapy will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
(I) EQ-5D-3L
(II) Physical health questionnaire
(iii)Treatment satisfaction
(Iv) Global perceived effect (GPE Scale) |
Before and after 7 days |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
10/03/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The aim of the study is to determine the whether Treatment satisfaction and outcome following a week of yoga and allied Therapies in patients attending a yoga therapy center for the management of their non-communicable diseases. 300 patients with non-communicable diseases will be recruited from a yoga therapy center for the study. |