Health Condition 1: M358- Other specified systemic involvement of connective tissue Health Condition 2: M340- Progressive systemic sclerosis
Conditions
Interventions
Intervention1: 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 (
Sponsors
Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh 221005
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in severity and frequency of Raynauds Phenomenon after introduction of drug with standard of careTimepoint: 0,6 and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Any untoward effect or hypersensitivityTimepoint: At 1 & 2 weeks | — |
Countries
India
Contacts
Public ContactSuraj Kumar Sha
Institute of Medical Sciences
Outcome results
None listed