| CTRI Number |
CTRI/2025/09/094066 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
01/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Analytical |
| Study Design |
Other |
|
Public Title of Study
|
Testing the Gujarati version of the MRC Breathlessness Scale in patients with breathing problems. |
|
Scientific Title of Study
|
Translation and Validation of Medical Research Council MRC Dyspnea Scale in Gujarati in Respiratory Patients with Dyspnea |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jenab Gulamhusenwala |
| Designation |
PG Student |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
Parul University Cardio OPD Room no 308 Limba Waghodiya Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
7990858863 |
| Fax |
|
| Email |
zainabgulamhusenwala@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Didhiti Desai |
| Designation |
Associate Professor |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
Parul University Cardio OPD Room no 308 Limda Waghodiya Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
88664 58302 |
| Fax |
|
| Email |
didhiti.desai@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Jenab Gulamhusenwala |
| Designation |
PG Student |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
Parul University Cardio OPD Room no 308 Limda Waghodiya Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
7990858863 |
| Fax |
|
| Email |
zainabgulamhusenwala@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Sevashram Hospital
Parul University Limba Waghodiya Vadodara 391760 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| Jenab Gulamhusenwala |
Parul Sevashram Hospital |
Parul University Cardio OPD Room no 308 Limda Waghodiya Vadodara
Vadodara
GUJARAT |
7990858863
zainabgulamhusenwala@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PU- IECHR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J22||Unspecified acute lower respiratory infection, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age from 35 to 60 years.
Subjects able to read and understand both English and Gujarati language properly.
Patients willing to sign consent form.
|
|
| ExclusionCriteria |
| Details |
Subjects with any other visual musculoskeletal cardiovascular or neurological impairments.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| MRC Dyspnea Scale |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="143"
Sample Size from India="143"
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)
|
18/09/2025 |
| 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
|
A Gujarati version of the MRC Dyspnea Scale would be more accessible to patients who are not English-speaking, ensuring accurate responses and better diagnosis. It would also help in understanding cultural nuances in expressing health symptoms, leading to more reliable data. This translation would enhance patient care by enabling more effective assessment and treatment of conditions like COPD, heart failure, and asthma. It would expand the scope of clinical research and diversify findings as well, for it will give more generalizable data. Validation is important to uphold the reliability of this scale, whether in a clinical or research-based setting. Hence, in simple words, translation and validation of MRC Dyspnea Scale to Gujarati will facilitate better care and inclusion of research. The translation of the scale in Gujarati varies among different therapists. Therefore, there is a need for a standardized scale that can be consistently administered to patients with dyspnea to ensure better understanding and interpretation.
|