| CTRI Number |
CTRI/2025/12/099567 [Registered on: 19/12/2025] Trial Registered Prospectively |
| Last Modified On: |
18/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To evaluate lung function whether restrictive, obstructive or mixed in rheumatoid arthritis patients who do not experience any symptoms |
|
Scientific Title of Study
|
To evaluate lung function in rheumatoid arthritis patients |
| 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 Surinder kumar Salwan |
| Designation |
Professor |
| Affiliation |
Sri guru ram das institute of medical sciences amritsar |
| Address |
Department of medicine, unit 5, sri guru ram das institute of medical sciences and research amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
9877788935 |
| Fax |
|
| Email |
surindersalwan05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surinder kumar Salwan |
| Designation |
Professor |
| Affiliation |
Sri guru ram das institute of medical sciences amritsar |
| Address |
Department of medicine, sri guru ram das institute of medical sciences and research amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
9877788935 |
| Fax |
|
| Email |
surindersalwan05@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Noorjeet Kaur |
| Designation |
Junior resident |
| Affiliation |
Sri guru ram das institute of medical sciences and research, amritsar |
| Address |
Department of medicine, sri guru ram das institute of medical sciences and research amritsar
Amritsar
PUNJAB
151505
India |
| Phone |
06283009808 |
| Fax |
|
| Email |
noorjeetkaur3001@gmail.com |
|
|
Source of Monetary or Material Support
|
| dept of medicine, sri guru ram das institue of medical sciences and research, amritsar |
|
|
Primary Sponsor
|
| Name |
Dept of medicine |
| Address |
Department of medicine, Sri guru ram das institute of medical sciences and research vallah amritsar |
| 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 Surinder kumar salwan |
Sri guru ram das institute of medical sciences and research, amritsar |
Department of medicine,Sri guru ram das institute of medical sciences and research, amritsar
Amritsar
PUNJAB |
9877788935
surindersalwan05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M051||Rheumatoid lung disease with rheumatoid arthritis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
adults aged more than 18 years
patients diagnosed with RA as per acr or eular criteria |
|
| ExclusionCriteria |
| Details |
known cases of active tuberculosis
smokers or ex- smokers
patients with acute respiratory infections
pregnant women
metastatic disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Restrictive pattern more common as compared to obstructive pattern in RA patients |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
29/12/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
To evaluate lung function in ra patients |