| CTRI Number |
CTRI/2018/11/016485 [Registered on: 30/11/2018] Trial Registered Prospectively |
| Last Modified On: |
04/05/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to look for dryness of eyes and mouth among patients suffering from Rheumatoid Arthritis |
|
Scientific Title of Study
|
A cross sectional study on the Prevalence of Secondary Sjögren’s Syndrome among patients with Rheumatoid Arthritis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sumeet Singla |
| Designation |
Associate Professor, Department of Medicine, Maulana Azad Medical College, New Delhi |
| Affiliation |
Department of Medicine |
| Address |
Room 115, First floor, BL Taneja Block, Maulana Azad Medical College, New Delhi
Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi
New Delhi
DELHI
110002
India |
| Phone |
01123501451 |
| Fax |
|
| Email |
sumeetsingla555@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sumeet Singla |
| Designation |
Associate Professor, Department of Medicine, Maulana Azad Medical College, New Delhi |
| Affiliation |
Department of Medicine |
| Address |
Room 115, First floor, BL Taneja Block, Maulana Azad Medical College, New Delhi
Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi
New Delhi
DELHI
110002
India |
| Phone |
01123501451 |
| Fax |
|
| Email |
sumeetsingla555@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumeet Singla |
| Designation |
Associate Professor, Department of Medicine, Maulana Azad Medical College, New Delhi |
| Affiliation |
Department of Medicine |
| Address |
Room 115, First floor, BL Taneja Block, Maulana Azad Medical College, New Delhi
Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi
New Delhi
DELHI
110002
India |
| Phone |
01123501451 |
| Fax |
|
| Email |
sumeetsingla555@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College, Bahadur Shah Zafar Marg New Delhi 110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Department of Medicine, Room no 115, First Floor, BL Taneja Block, Maulana Azad Medical College, New Delhi, 110002 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Indian Council of Medical Research |
Ansari Nagar, New Delhi - 110029 |
| Maulana Azad Medical College and associated Hospitals |
Bahadur Shah Zafar Marg, New Delhi, 110002 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sumeet Singla |
MAMC, Lok Nayak Hospital, and GB Pant Hospital, New Delhi |
Department of Medicine, Room No 115, First Floor, B L Taneja block
New Delhi
DELHI |
01123501451
sumeetsingla555@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Medical College and Associated Hospitals, New Delhi, 110002 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M05||Rheumatoid arthritis with rheumatoid factor, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All adult (>18 years) patients of Rheumatoid Arthritis, who meet the ACR/EULAR 2010 Classification criteria, and give informed consent, will be included in the study. |
|
| ExclusionCriteria |
| Details |
Rheumatoid Arthritis patients with previous head and neck radiation treatment, hepatitis C infection,diabetes, thyroid disease,HIV/AIDS, preexisting lymphoma, sarcoidosis,history of organ transplant/graft-versus-host disease and use of anti cholinergics/anti depressants/diuretics/anti allergic drugs, will not be recruited.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Secondary Sjogrens syndrome |
At the time of recruitment into study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary Sjogrens syndrome |
At the time of recruitment into study |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "155"
Final Enrollment numbers achieved (India)="155" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/12/2018 |
| Date of Study Completion (India) |
04/04/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
04/04/2019 |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is an observational Cross sectional study, that will assess the prevalence of Secondary Sjögren’s Syndrome among patients of Rheumatoid Arthritis and to find associated clinical and demographic risk factors for development of the same. It will be conducted in the Department of Rheumatology, Maulana Azad Medical College and associated Lok Nayak Hospital, over a period of 3 months, starting 1 December 2018, recruiting 100 participants. |