| CTRI Number |
CTRI/2024/07/069866 [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 see if Telmisartan helps to improve the symtoms of Raynauds Phenomena (discoloration/pain in fingers on exposure to cold temperatures) in patients of Systemic sclerosis or MCTD |
|
Scientific Title of Study
|
Open label randomised controlled trial of telmisartan in Raynauds phenomena associated with progressive systemic sclerosis and mixed connective tissue disorder |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Suraj Kumar Sha |
| Designation |
Junior Resident |
| Affiliation |
Institute of Medical Sciences |
| Address |
Department of General Medicine
Institute of Medical Sciences
Banaras Hindu University
Varanasi
Uttar Pradesh
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8170005186 |
| Fax |
|
| Email |
surajsha96@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
Uttar Pradesh
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
6392194981 |
| Fax |
|
| Email |
dgautam@bhu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Suraj Kumar Sha |
| Designation |
Junior Resident |
| Affiliation |
Institues of Medical Sciences Banaras Hindu University |
| Address |
Department of General Medicine
Institute of Medical Sciences
Banaras Hindu University
Varanasi
Uttar Pradesh 221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8170005186 |
| Fax |
|
| Email |
surajsha96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Medical Sciences
Banaras Hindu University
Varanasi
Uttar Pradesh 221005 |
|
|
Primary Sponsor
|
| Name |
Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh 221005 |
| Address |
Institute of Medical Sciences
Banaras Hindu University
Varanasi
Uttar Pradesh 221005 |
| 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
Sir Sunder Lal Hospital
Institute of Medical Sciences
Banaras Hindu University
Varanasi
Uttar Pradesh 221005
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: M358||Other specified systemic involvement of connective tissue, (2) ICD-10 Condition: M340||Progressive systemic sclerosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nifedipine (10 - 20mg) |
Once a diagnosis of progressive systemic sclerosis or MCTD with Raynauds Phenomena is made, the patients are given SOC (Tadalafil and protective precautions) with Tablet. Nifedipine (10- 20mg) (as permissible by blood pressure) orally thrice daily for 12 weeks and followed up at 6 and 12 weeks in between the months of November to February to look for the frequency and severity of Raynauds Phenomena with the help of Raynauds condition score (translated in hindi) |
| Intervention |
Telmisartan plus SOC (Tadalafil plus cold protective measures) |
Once a diagnosis of progressive systemic sclerosis or MCTD with Raynauds Phenomena is made, the patients are given SOC (Tadalafil and protective precautions) with Tablet. Telmisartan (20mg - 40mg)(as permissible by blood pressure) orally once daily for 12 weeks and followed up at 6 and 12 weeks in between the months of November to February to look for the frequency and severity of Raynauds Phenomena with the help of Raynauds condition score (translated in hindi) |
|
|
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 sclerosis or MCTD with history of Raynauds Phenomena
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
Patient with symptomatic CAD |
|
|
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 & 2 weeks |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/11/2024 |
| 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 Applicable |
| 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
|
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) from the month of November to February, 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 |