| CTRI Number |
CTRI/2024/07/069868 [Registered on: 03/07/2024] Trial Registered Prospectively |
| Last Modified On: |
02/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To check the efficacy if Telmisartan in Raynauds phenomenon associated with Systemic Lupus Erythematosus and Rheumatoid Arthritis |
|
Scientific Title of Study
|
Open label randomised controlled trial of Telmisartan in Raynauds phenomenon associated with Systemic Lupus Erythematosus and 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 |
Rajat Singh |
| Designation |
Junior Resident |
| Affiliation |
Institute of Medical Sciences |
| Address |
Department of General Medicine
Institute of Medical Sciences
Banaras Hindu University
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8400035023 |
| Fax |
|
| Email |
rajatyadav0001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Deepak K Gautam |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences |
| Address |
Division of Rheumatology
Department of General Medicine
Institute of Medical Sciences
Banaras Hindu University
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
6392194981 |
| Fax |
|
| Email |
dgautam@bhu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Rajat Singh |
| Designation |
Junior Resident |
| Affiliation |
Institues of Medical Sciences Banaras Hindu University |
| Address |
Department of General Medicine
Institute of Medical Sciences
Banaras Hindu University
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8400035023 |
| Fax |
|
| Email |
rajatyadav0001@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Medical Sciences
Banaras Hindu University
Varanasi
221005 |
|
|
Primary Sponsor
|
| Name |
Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh 221005 |
| Address |
Department of General Medicine
Institute of Medical Sciences
Banaras Hindu University
Varanasi |
| 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 Deepak K Gautam |
Sir SunderLal Hoapital, BHU |
Rheumatology OPD Room no 217
Division of Rheumatology
Department of General Medicine
Institute of Medical Sciences
Banaras Hindu University
Varanasi
Varanasi
UTTAR PRADESH |
6392194981
dgautam@bhu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BANARAS HINDU UNIVERSITY INSTITUTE OF MEDICAL SCIENCES, VARANASI, INDIA 221005 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M056||Rheumatoid arthritis with involvement of other organs and systems, (2) ICD-10 Condition: M321||Systemic lupus erythematosus withorgan or system involvement, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nifedipine (10 - 20mg) + standard of care (tadalafil and cold protective measures) |
Once the diagnosis of either SLE OR Rheumatoid arthirits with Raynauds Phenomena is made 10 patients will be given Tablet.Nifedipine (10 - 20mg) (as permissible by blood pressure) orally thrice daily for 12 weeks plus SOC, and then followed up at 6 and 12 weeks and evaluated for the severity and frequency of Raynauds Phenomenon with the help of Raynauds Condition score and its hindi translation. |
| Intervention |
Telmisartan + standard of care (Tadalafil with cold protective measures) |
Once the diagnosis of either SLE OR Rheumatoid arthirits with Raynauds Phenomena is made 10 patients will be given Tablet. Telmisartan (20 - 40mg) (as permissible by blood pressure) orally once daily for 12 weeks plus SOC, and then followed up at 6 and 12 weeks and evaluated for the severity and frequency of Raynauds Phenomenon with the help of Raynauds Condition score and its hindi translation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age greater than or equal to 18 years.
2. Patients diagnosed as Systemic Lupus Erythematosus and Rheumatoid Arthritis
with history of Raynaud’s Phenomenon.
3. Willing to give signed written consent.
|
|
| ExclusionCriteria |
| Details |
1.Any co-existing significant/incapacitating chronic illness
2.Patient with symptomatic CAD
3.Patients on oral or sublingual nitrates
4.Patient who are pregnant or reproductive couples who have intention of pregnancy
5.Patients with known contraindication to either of IPs or SOC |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in severity and frequency of Raynauds Phenomenon after introduction of drug with standard of care |
0,6 and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Any untoward effect or hypersensitivity |
At 1 and 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/11/2024 |
| Date of Study Completion (India) |
28/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Registered cases will randomised into 2 groups of 10 patients each, all patients will receive standard of care ( Tadalafil with cold protective measures), one arm of the study (10patients) will receive Telmisartan (20- 40mg) and the other group will receive Nifedipine (10 - 20mg), they will be then followed up at 6 and 12 weeks with Raynauds condtion score which will assess the frequency and severity of Raynauds Phenomenon |