Study of Qifangfeixian Granules for Treating Connective Tissue Disease-Associated Interstitial Lung Disease in Adults

What this Trial Is About

Interstitial lung disease ILD is a group of diseases involving inflammation or scarring in the lungs, with connective tissue disease-associated ILD CTD-ILD being a common form. CTD-ILD can occur with a known diagnosis of connective tissue disease or with related symptoms and lab findings. Treatments currently include hormones and immunosuppressants, which may cause serious side effects like infection and increased cancer risk. This research aims to evaluate the effectiveness and safety of Qifangfeixian granules, a traditional Chinese medicine, as a potential treatment for CTD-ILD. This randomized, placebo-controlled, multicenter study will compare Qifangfeixian granules to a placebo in patients with fibrotic CTD-ILD. Participants will be randomly assigned to receive either 1 bag of Qifangfeixian granules or a placebo twice daily. The study plans to enroll 124 subjects divided equally between the treatment and placebo groups. Dose adjustments may be made during treatment, and participants will be followed for 4 weeks if they withdraw early. The study will monitor for adverse events and medication safety throughout. Participants will attend visits for safety assessments including imaging with high-resolution CT scans, blood and urine tests, electrocardiograms, vital signs, and physical exams. Clinical data and patient questionnaires will be collected at specific time points. The primary outcome is lung function measured by forced vital capacity over 12 weeks. Secondary outcomes include hormone dosage changes and symptom scores related to pulmonary fibrosis. The study duration and follow-up details are planned according to the protocol to assess both effectiveness and safety.

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Qifangfeixian Granules in the Treatment of Connective Tissue Disease-Associated Interstitial Lung Disease (CTD-ILD)