Clinical trial: Clinical Trial of Chinese Herbal Medicine for Idiopathic Pulmonary Fibrosis (IPF) (NCT03274544)

Eligibility criteria:
Inclusion Criteria:

          -  Either gender aged 40-75;

          -  Has a diagnosis of IPF, made by a respiratory expert based on International
             Classification of Diseases (ICD-10);

          -  No participation in another clinical study within 4 weeks of study start.

          -  Participation in this study must be voluntary and not coerced.

        Exclusion Criteria:

          -  Have received lung transplantation.

          -  Any condition that may compromise patient safety.

          -  Pregnant women or women trying to become pregnant will be excluded from the study.

          -  History of drug or alcohol abuse within 6 months of study start.

          -  History of immunocompromise, including a positive HIV test result.

          -  Impaired liver and renal functions.

          -  Known allergies to any Chinese herbs and participants with numerous or severe
             allergies to any allergen.

          -  Pre-existing conditions including renal failure, chronic renal problems, chronic
             hepatitis, other pulmonary problems, diabetes, and heart problems will be excluded
             from the study.

          -  Either mentally incompetent or are unable to give informed consent because of the
             language barrier.

          -  Taking the following drugs, even as part of their current treatment regimen for IPF:
             pirfenidone, nintedanib, antiplatelet drugs (including aspirin, clopidogrel (Plavix),
             and dipyridamole (Persantine), anticoagulant drugs (including warfarin (Coumadin),
             enoxparin (Lovenox), and heparin), cardiac glycosides (e.g. digoxin), sedatives and
             sedative-containing drugs (including barbiturates, narcotic analgesics,
             benzodiazepines, and antihistamines), and traditional Chinese herbal medicines or
             granules, or other herbal medicines or supplements.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 75 Years

Patient description (medical language): A 47-year-old man comes to the office for routine checkup. He is complaining of chronic cough and occasional but progressive dyspnea.  Other medical conditions include hypertension and osteoarthritis.  The patient smokes a pack of cigarettes daily and does not use alcohol or illicit drugs.  He used to be a construction worker. On examination, there are decreased breath sounds and percussive dullness at the base of both lungs.  Chest CT scan reveals a mild bilateral pleural effusion and diffuse thickening of the pleura. The patient's documents show chronic exposure to asbestosis. The specimen of the lungs reveled  pulmonary fibrosis that is most predominant in the lower lobes, characterized  by the presence of asbestos bodies (golden-brown beaded rods with translucent centers).

Patient description (patient's own words): I'm a 47-year-old former construction worker. I'm a man and I smoke a pack of cigs a day but I don't drink or do drugs. I went to my routine checkup because I've been coughing so much lately. I also had shortness of breath and it got worse over time. I already suffer from hypertension and osteoarthritis. My doctor found that I have decreased breath sounds. I did a chest scan and it seems that I have fluid around my lungs, and the lining of my lungs has become thicker in many areas. I have been exposed a lot to asbestos fibers. The other lung exam showed that I have pulmonary fibrosis, especially in the lower part of my lungs and they found some asbestos there.

Does the patient match the trial criteria? 1