| CTRI Number |
CTRI/2025/09/094303 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
04/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Awareness and Practices of Yoga in the Management of Diabetic Neuropathy in the General Population and Health Care Professionals |
|
Scientific Title of Study
|
Knowledge Attitudes and Practices of Yoga in the Management of Diabetic Neuropathy amongst the General Population and Health Care Professionals |
| 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 Dipali Suvarna PT |
| Designation |
Associate Professor |
| Affiliation |
K J Somaiya College of Physiotherapy |
| Address |
OPD 11 K J Somaiya College of Physiotherapy
Ayurvihar Eastern Express Highway
Everard nagar
Sion Mumbai 400022
Mumbai (Suburban)
MAHARASHTRA
400022
India |
| Phone |
08356964432 |
| Fax |
|
| Email |
dipali.suvarna@somaiya.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chaitali Shah PT |
| Designation |
Associate Professor |
| Affiliation |
Parul University |
| Address |
Neuro physiotherapy Department
Parul University
Limda Vadodara
Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
2668260300 |
| Fax |
|
| Email |
chaitali.shah@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dipali Suvarna PT |
| Designation |
Associate Professor |
| Affiliation |
K J Somaiya College of Physiotherapy |
| Address |
OPD 11 K J Somaiya College of Physiotherapy
Ayurvihar
Eastern Express Highway Everard nagar Sion Mumbai 400022
Mumbai (Suburban)
MAHARASHTRA
400022
India |
| Phone |
08356964432 |
| Fax |
|
| Email |
dipali.suvarna@somaiya.edu |
|
|
Source of Monetary or Material Support
|
| OPD 11 K J Somaiya College of Physiotherapy
Ayurvihar
Eastern Express Highway Everard nagar Sion Mumbai 400022 |
|
|
Primary Sponsor
|
| Name |
K J Somaiya College of Physiotherapy |
| Address |
OPD 11 Ayurvihar Eastern express highway Everard Nagar Sion Mumbai 400022 |
| Type of Sponsor |
Private medical college |
|
|
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 Dipali Suvarna PT |
K J Somaiya College of Physiotherapy |
OPD 11 Ayurvihar Eastern express highway Everard nagar Sion Mumbai 400022
Mumbai (Suburban)
MAHARASHTRA |
08356964432
dipali.suvarna@somaiya.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe K J Somaiya College of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
any person in general population and health care profession to be screened for their knowledge attitude and practices of Yoga in management of diabetic neuropathy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
For general population
Individuals of any gender in the age group of 20 to 80 years
For Health care professionals
Practicing doctors and allied health professionals |
|
| ExclusionCriteria |
| Details |
Any diagnosed psychiatric illness |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Knowledge attitude and practices |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="264"
Sample Size from India="264"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/09/2025 |
| Date of Study Completion (India) |
05/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
In this study Separate Structured questionnaires for General Population and Health Care Professionals are made content validity would be calculated after review from experts Recruitment of participants will be done on the basis of inclusion and exclusion criteria The study procedure will be explained to the participants and consent would be taken Participants will be interviewed & Data sheet would be filled Data thus obtained will be analyzed statistical analysis will be done and inferences would be drawn Outcome measures with its reliability and validity Statistical tests to be used with reasoning: Descriptive statistics would be represented in percentages mean mode or standard deviation & would be done in the form of charts and tables |