Pulmonary Fibrosis. Other interstitial pulmonary diseases with fibrosis
Conditions
Interventions
Intervention 1: Fibrangi, 1 capsule three times a day for 6 month and 1 capsule two times a day for three months a day. Intervention 2: Placebo, 1 capsule three times a day for 6 month and 1 capsule t
Treatment - Drugs
Fibrangi, 1 capsule three times a day for 6 month and 1 capsule two times a day for three months a day
Placebo, 1 capsule three times a day for 6 month and 1 capsule two times a day for three months
Sponsors
Pars Roos Biotechnology Co.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: 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
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DLCO. Timepoint: Every 45 days during study period and three months after discontinuation of treatment. Method of measurement: Body Box test. | — |
Secondary
| Measure | Time frame |
|---|---|
| Dyspnea and cough. Timepoint: Every 45 days during treatment period and three months after discontinuation of treatment. Method of measurement: MRC questionnaire.;FEV1/ FVC/ RV. Timepoint: Every 45 days during treatment period and three months after discontinuation of treatment. Method of measurement: Spirometry/PFT.;SaO2. Timepoint: Every 45 days during treatment period and three months after discontinuation of treatment. Method of measurement: Arterial blood O2 saturation.;TLC. Timepoint: Every 45 days during treatment period and three months after discontinuation of treatment. Method of measurement: body boxing method.;Mortality rate. Timepoint: Every 45 days during treatment period and three months after discontinuation of treatment. Method of measurement: Death during study period.;Quality of life. Timepoint: Every 45 days during treatment period and three months after discontinuation of treatment. Method of measurement: SF12 questionnaire.;6MWT. Timepoint: Every 45 days during treatment period and three months after discontinuation of treatment. Method of measurement: This is the distance that a patient can walk during 6 minutes. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Ommolbanin Paknejad
Tehran University of Medical Sciences
Outcome results
None listed