Systemic Sclerosis (SSc) Musculoskeletal Diseases Systemic sclerosis
Conditions
Interventions
The patients are divided into 2 groups:
Group 1: assigned to receive 40 mg/day of atorvastatin for four months
Group 2: assigned to identical placebo tablets for four months
Seventy-five healthy age
Sponsors
University of Alexandria (Egypt)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Raynaud's phenomenon 2. A history of a documented digital ulcer secondary to SSc within the last 12 months despite ongoing vasodilator therapy 3. Aged between 25 - 60 years, both male and female
Exclusion criteria
Exclusion criteria: 1. Smoking 2. Diabetes mellitus 3. Hypercholesterolaemia 4. Hypertension 5. Cardiac insufficiency 6. Coexisting hepatic and renal diseases and drugs known to interact with statins
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is the number of new digital ulcers occurring during the study period, measured monthly. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The Scleroderma Health Assessment Questionnaire subsets for dressing/grooming (SHAQ-DI) 2. Eating and hand grip 3. Assessment of safety and tolerability of the atorvastatin therapy All secondary outcomes are measured monthly. | — |
Countries
Egypt
Outcome results
None listed