| CTRI Number |
CTRI/2025/10/096355 [Registered on: 22/10/2025] Trial Registered Prospectively |
| Last Modified On: |
22/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of self efficacy on treatment outcomes |
|
Scientific Title of Study
|
To determine if the dimensions of patients’ self-efficacy influence the treatment outcomes 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 |
Research Advisor |
| Affiliation |
Patanjali Research Foundation (Trust) |
| Address |
Department of Yoga Research, 2nd floor, Sadbhawana Building, Patanjali Research Foundation (Trust), Patanjali Yogpeeth Phase 1, Bahadrabad, Hardwar 249405 Uttaranchal, India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
09897963254 |
| Fax |
|
| Email |
shirleytelles@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shirley Telles |
| Designation |
Research Advisor |
| Affiliation |
Patanjali Research Foundation (Trust) |
| Address |
Department of Yoga Research, 2nd floor, Sadbhawana Building, Patanjali Research Foundation (Trust), Patanjali Yogpeeth Phase 1, Bahadrabad, Hardwar 249405 Uttaranchal, India
UTTARANCHAL
249405
India |
| Phone |
09897963254 |
| Fax |
|
| Email |
shirleytelles@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shirley Telles |
| Designation |
Research Advisor |
| Affiliation |
Patanjali Research Foundation (Trust) |
| Address |
Department of Yoga Research, 2nd floor, Sadbhawana Building, Patanjali Research Foundation (Trust), Patanjali Yogpeeth Phase 1, Bahadrabad, Hardwar 249405 Uttaranchal, India
UTTARANCHAL
249405
India |
| Phone |
09897963254 |
| Fax |
|
| Email |
shirleytelles@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Yoga Research, 2nd floor, Sadbhawana Building, Patanjali Research Foundation (Trust), Patanjali Yogpeeth Phase 1, Bahadrabad, Hardwar 249405 Uttaranchal, India |
|
|
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 249405 Uttaranchal, 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 |
Patanjali Research Foundation (Trust) |
Department of Yoga Research, 2nd floor, Sadbhawana Building, Patanjali Research Foundation (Trust), Patanjali Yogpeeth Phase 1, Bahadrabad, Hardwar 249405 Uttaranchal, India
Hardwar
UTTARANCHAL |
09897963254
shirleytelles@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Patanjali Research Foundation Trust |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Integrated therapies including yoga and allied therapies |
Time points: (i) Before the intervention(Pre): At the start of integrated therapy (ii)Duration of integrated therapies: 7 days. (iii) After the intervention(Post): After 7 days of integrated therapy |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients who will be visiting integrated therapy center for their treatment |
|
| ExclusionCriteria |
| Details |
Patients who will return incomplete questionnaires or will not complete 7 days of treatment |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Self-efficacy questionnaire
2. EQ-5D-5L
3. Physical Health Questionnaire
4. The Global Perceived Effect Scale |
1. Self-efficacy questionnaire will be assessed at baseline (i.e., at day 0)
2. The EQ-5D-5L will be assessed at baseline (i.e., at day 0) and after seven days of treatment
3. Physical Health Questionnaire will be assessed at baseline (i.e., at day 0) and after seven days of treatment
4. The Global Perceived Effect Scale will be assessed at day 7.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
07/11/2025 |
| 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 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
|
The objective of the study is to assess the effect of patients self efficacy on treatment outcomes in various spectrum of diseases in an integrated therapy center in north India. |