Evaluating the effect of tropical sildenafil gel on incidence and severity of Raynaud’s Phenomenon Attacks in patients with systemic sclerosis: A double blinded randomized clinical trial
Phase 3
Recruiting
- Conditions
- systemic sclerosis.Systemic sclerosis [scleroderma]
- Registration Number
- IRCT20240203060886N1
- Lead Sponsor
- Shahre-kord University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
Age over 18 and under 75 years
Patients with systemic sclerosis diagnosed by ACR criteria or LeRoy ? Medsger
Willingness to participate in the clinical trial
Absence of MI, stroke or cardiac arrhythmia in recent 6 month
Skin involvement limited to fingers, hands, face, forearms and feet
Exclusion Criteria
History of CKD (Creatinine clearance under ?? ml/minute) or cirrhosis (Child-Pugh class C)
Overlap syndrome
Hypersnsitivity to topical sildenafil
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Severity of pain. Timepoint: Measurement of pain severity before the intervention and 2 and 6 weeks after the intervention. Method of measurement: Visual Analogue Scale (VAS) Questionnaire.;Quality of life. Timepoint: Measuring different aspects of quality of life before the intervention and 2 and 6 weeks after the intervention. Method of measurement: The World Health Organization Quality of Life Brief Version (WHOQOL-BREF).;Capiloroscopy of the nail bed of patients. Timepoint: before the intervention and 2 and 6 weeks after the intervention. Method of measurement: nailfold capiloroscope.
- Secondary Outcome Measures
Name Time Method