Effectiveness of treatment with Fibrangi in Idiopathic Pulmonary Fibrosis: A Randomised double-blind controlled clinical trial
- Conditions
- Pulmonary Fibrosis.Other interstitial pulmonary diseases with fibrosis
- Registration Number
- IRCT138806152425N1
- Lead Sponsor
- Pars Roos Biotechnology Co.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 20
Diagnosis of IPF according to ATS (American Thoracic Society) criteria (based on histological, clinical and radiological findings), duration of IPF more than three month, FVC = 55-90% of predicted value, DLCO > 35% of predicted value, PaO2 >7.3 kpg( in rest and room air condition), signing informed consent form
Exclusion criteria: receiving interferon ?, antiplatelets, or anticoagulation drugs (Aspirin, Warfarin, Dipyridamole, …), presence of other chronic progressive lung diseases (such as COPD), presence of connective tissue disorders, FEV1 to FVC ratio less than 60% after receiving bronchodilators, residual volume > 120%, positive stool strongyloidosis, pregnancy or intention of becoming pregnant during the study period (1 year), breast feeding, presence of serious and unstable cardiac condition, presence of severe neurologic disorders, abnormal liver function tests, bilirubin more than twice the normal limit, AST more than twice the normal limit, abnormal PT test (INR more than 1.5), presence of active malignancy, presence of any other condition (other than IPF) that is likely to cause death in the coming year, Inability to give informed consent according to the agreed process
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method DLCO. Timepoint: Every 45 days during study period and three months after discontinuation of treatment. Method of measurement: Body Box test.
- Secondary Outcome Measures
Name Time Method