| CTRI Number |
CTRI/2025/09/094911 [Registered on: 16/09/2025] 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 |
Other |
|
Public Title of Study
|
Study on how rheumatoid arthritis affects sleep, joint problems, and arm use. |
|
Scientific Title of Study
|
Association between sleep problems, disease activity, and upper limb dysfunction in patients with rheumatoid arthritis. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anjali Sharma |
| Designation |
Post Graduate Student |
| Affiliation |
College of Physiotherapy, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences |
| Address |
Physiotherapy Department, E-Block College of Physiotherapy, PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9586397416 |
| Fax |
|
| Email |
anjalisharma78o9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meetu |
| Designation |
Associate Professor |
| Affiliation |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences |
| Address |
Physiotherapy Department, Faculty Room, E- Block, College of Physiotherapy, PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9416403155 |
| Fax |
|
| Email |
meetunagpalpt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anjali Sharma |
| Designation |
Post Graduate Student |
| Affiliation |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences |
| Address |
Physiotherapy Department, E- Block, College of Physiotherapy, PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9586397416 |
| Fax |
|
| Email |
anjalisharma78o9@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of Physiotherapy, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, Rohtak 124001 |
|
|
Primary Sponsor
|
| Name |
College of Physiotherapy, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences |
| Address |
Faculty room, E-Block, College of Physiotherapy, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences, UHS, Rohtak Haryana 124001, India |
| Type of Sponsor |
Government 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 Anjali Sharma |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences |
Department of Rheumatology, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences
Rohtak
HARYANA |
9586397416
anjalisharma78o9@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical research ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M069||Rheumatoid arthritis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed patients of Rheumatoid Arthritis fulfilling 2010 ACR EULAR Criteria
Disease duration more than 1 year |
|
| ExclusionCriteria |
| Details |
Other autoimmune diseases, severe comorbidities (eg diabetes, cardiovascular).
Recent upper extremity injury.
Sleep disorders or medications affecting sleep (eg sedatives, corticosteroids).
Neurological disorders.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
SLEEP PROBLEMS
DISEASE ACTIVITY
UPPER LIMB DYSFUNCTION |
On Day 0 (Baseline) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
20/09/2025 |
| 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
|
This study will be conducted on patients diagnosed with rheumatoid arthritis (RA) as per the 2010 ACR/EULAR criteria, referred from the OPD of the Department of Rheumatology, PGIMS, UHS Rohtak. Eligible participants will be adults (>18 years) with disease duration >1 year. Patients with other autoimmune diseases, severe comorbidities, neurological disorders, recent upper extremity injuries, sleep disorders, or medications affecting sleep will be excluded. Data collection will include demographic details, sleep quality (Pittsburgh Sleep Quality Index), disease activity (DAS28-ESR), and upper limb dysfunction (DASH questionnaire). Written informed consent will be obtained, and data will be collected in a structured and confidential manner.
|