Effect of N acetylcysteine on pulmonary function in patients with scleroderma
Phase 2
- Conditions
- lung involvement in scleroderma.Respiratory disorders in other diffuse connective tissue disorders (systemic sclerosis)
- Registration Number
- IRCT2014012616367N1
- Lead Sponsor
- Vice chancellor for research, Shiraz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
Cases of diffuse scleroderma who fulfilled the ACR criteria for systemic sclerosis that diagnosis of their disease was made less than one year ago; No evidence of fibrosis in high rsolution CT scan (HRCT)
Exclusion criteria:
Lung involvement (deterioration of disease); Not properly usage of drug; Not regularly visits by cases in intervals and appointments that were determined for them; Not toleration of drug or probable allergic reactions to it (very rare reports); Clinical or serologic evidence of other collagen vascular disease; History of exposure to known fibrogenic agents; Previous use of immunosuppressive or corticosteroid therapy for a minimum of 6 months before entering the study.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total lung capacity. Timepoint: At the beginning and 6 months following start of intervention. Method of measurement: Body plethysmography measured by litre.;Diffusing capacity. Timepoint: At the beginning and 6 months following start of intervention. Method of measurement: DLCO ml/min.;Vital capacity. Timepoint: At the beginning and 6 months following start of intervention. Method of measurement: Body plethysmography.
- Secondary Outcome Measures
Name Time Method Adverse drug/placebo reaction. Timepoint: Every 2 months. Method of measurement: Ask from the patient.