| CTRI Number |
CTRI/2025/09/094633 [Registered on: 11/09/2025] Trial Registered Prospectively |
| Last Modified On: |
11/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Translation and Validation of Clinical COPD Questionnaire in Odia |
|
Scientific Title of Study
|
Cross-cultural adaptation, Validation and Reliability of Clinical Chronic Obstructive Pulmonary Disease Questionnaire in Odia. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SOUGAT SUMAN SETHA |
| Designation |
MASTER OF PHYSIOTHERAPY STUDENT |
| Affiliation |
Abhinav Bindra Sports Medicine and Research Institute |
| Address |
Abhinav Bindra Sports Medicine and Research Institute, Utkal Signature, Plot 269 and 273, NH5 Pahal, Bhubaneshwar, Odisha
Khordha
ORISSA
752101
India |
| Phone |
9861728171 |
| Fax |
|
| Email |
sougat.physio0509@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PRIYADARSHINI MISHRA |
| Designation |
ASSOSCIATE PROFESSOR |
| Affiliation |
ABHINAV BINDRA SPORTS MEDICINE AND RESEARCH INSTITUTE |
| Address |
Abhinav Bindra Sports Medicine and Research Institute, Utkal Signature, Plot 269 and 273, NH5 Pahal, Bhubaneshwar, Odisha
Khordha
ORISSA
752101
India |
| Phone |
9438150665 |
| Fax |
|
| Email |
priyadarshinimishra@absmari.com |
|
Details of Contact Person
Public Query
|
| Name |
SOUGAT SUMAN SETHA |
| Designation |
MASTER OF PHYSIOTHERAPY STUDENT |
| Affiliation |
Abhinav Bindra Sports Medicine and Research Institute |
| Address |
Abhinav Bindra Sports Medicine and Research Institute, Utkal Signature, Plot 269 and 273, NH5 Pahal, Bhubaneshwar, Odisha
Khordha
ORISSA
752101
India |
| Phone |
9861728171 |
| Fax |
|
| Email |
sougat.physio0509@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SOUGAT SUMAN SETHA |
| Address |
Abhinav Bindra Sports Medicine and Research Institute, Utkal Signature, Plot 269 and 273, NH5 Pahal, Bhubaneswar, Odisha |
| 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 |
| DR SOUGAT SUMAN SETHA |
Abhinav Bindra Sports Medicine and Research Institute |
ABSMARI, Department of Cardiopulmonary Sciences, Utkal Signature, Plot 269 and 273, NH5 Pahal, Bhubaneshwar, Odisha
Khordha
ORISSA |
9861728171
sougat.physio0509@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ABSMARI ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J00-J99||Diseases of the respiratory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Individuals should be able to read and understand vernacular Odia. They should be categorised in COPD according to GOLD criteria. |
|
| ExclusionCriteria |
| Details |
Individuals who are unable to read or understand the Odia language. Individuals suffering from any respiratory conditions other than COPD |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Content Validity Index |
After 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
22/09/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This study is a non-interventional, cross-sectional validation study that aims to develop and validate an Odia version of the CCQ that retains the semantic integrity of the original English version.
Method of Translation: Standard forward-backwards translation Procedure
Inclusion Criteria:
Age: 19 to 40 years
Individuals who can read and understand vernacular Odia
Diagnosed as COPD under GOLD Criteria
Exclusion Criteria:
Not
able to read or understand Odia, Patients affected with Respiratory
Conditions other than COPD such as Patients with chronic respiratory failure,
psychiatric disorders, pregnancy and lactation, uncontrolled systemic illnesses
or life-threatening infections, vital organ failure, and those with substance
abuse and/or dependence were excluded from the study.
|