CTRI/2024/07/069866Not yet recruitingPhase 2
Open label randomised controlled trial of telmisartan in Raynauds phenomena associated with progressive systemic sclerosis and mixed connective tissue disorder
Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh 2210051 site in 1 country20 target enrollmentStarted: November 1, 2024Last updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Improvement in severity and frequency of Raynauds
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Improvement in severity and frequency of Raynauds
Time Frame: 0,6 and 12 weeks
Phenomenon after introduction of drug with
Time Frame: 0,6 and 12 weeks
standard of care
Time Frame: 0,6 and 12 weeks
Secondary Outcomes
- Any untoward effect or hypersensitivity(At 1 & 2 weeks)
Investigators
Suraj Kumar Sha
Institute of Medical Sciences
Study Sites (1)
Loading locations...
Similar Trials
Not yet recruiting
Phase 2
Effect of Ayurvedic medicine in Hypothyroidism.CTRI/2025/02/081276Shraddha Dattatray Satre80
Not yet recruiting
Not Applicable
To study the effectiveness of Varmam manipulation technique with Murivu Ennai (External medicine) for the management of Anterior Cruciate Ligament InjuryCTRI/2024/06/068801National Institute of Siddha20
Completed
Phase 1
This is a clinical trial (study), to be conducted at multiple clinical sites, of an oral study drug (EP262) that will be investigated in adult participants with Chronic Inducible Urticaria (CIndU) to assess if it is safe and improves reactions to known CIndU triggers.2023-504800-28-00Escient Pharmaceuticals Inc.14
Recruiting
Not Applicable
A comparative study to assess the effect of the addition of dexamethasone (a steroid drug) to commonly used pain killers, on the pain relief after keyhole surgery for oesophageal cancer at a cancer institute.CTRI/2025/09/094658Tata Memorial Hospital, Mumbai, India60
Recruiting
Not Applicable
A Prospective Randomised Study of Treatment Selection Based on Epigenetic Markers Versus Standard of Care Treatment Selection in Adults With CROHN's DiseaseNCT07363044Alimentiv Inc.378