Efficacy and Safety of Jin-Shui Huan-Xian Granule for Idiopathic Pulmonary Fibrosis: Study Protocol for a Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial

Abstract

Background Idiopathic pulmonary fibrosis is a critical disease with poor prognosis. Although different studies have been conducted for the treatment of idiopathic pulmonary fibrosis, limited treatments are available. Jin-shui Huan-xian granule, which is a Chinese medicine herbal compound, has shown a promising efficacy in reducing frequencies of acute exacerbations, improving exercise capacity the quality of life of patients for idiopathic pulmonary fibrosis. Subjects and Methods: This is a multicenter, randomized, double-blind, placebo-controlled clinical trial. A total of 312 idiopathic pulmonary fibrosis patients will be enrolled and randomly allocated to one of the two groups with 1:1. After a 2-week washout period, 52-week treatment will also be performed for all the patients. Patients in experimental group will be given Jin-shui Huan-xian granule with Jin-shui Huan-xian placebo for control group. Outcome measures including acute exacerbations, pulmonary function, dyspnea, exercise capacity, quality of life will be evaluated in this study. Discussion Based on our previous study, it is hypothesized that JHG will reduce the acute exacerbations, improve exercise capacity, pulmonary function, quality of life, delay the disease progression-free. High-level evidence-based support for TCM in IPF will also be obtained in this study. Trial registration: http:www.clinicaltrials.gov : NCT04187690. Register data: December 11, 2019.