Efficacy and safety of Jin-shui Huan-xian granule for idiopathic pulmonary fibrosis: study protocol for a multicenter, randomized, double-blind, placebo-controlled trial
Shu-guang Yang,
Xue-qing Yu,
Jian-sheng Li,
Yang Xie,
Wei Zhang,
Chengjun Ban,
Jihong Feng,
Lei Wu,
Xuechao Lu,
Limin Zhao,
Yong Meng,
Miao Zhou,
Yong He,
Weixian Luo
Affiliations
Shu-guang Yang
Co-construction Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases by Henan & Education Ministry of People’s Republic of China, Henan University of Chinese Medicine
Xue-qing Yu
Co-construction Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases by Henan & Education Ministry of People’s Republic of China, Henan University of Chinese Medicine
Jian-sheng Li
Co-construction Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases by Henan & Education Ministry of People’s Republic of China, Henan University of Chinese Medicine
Yang Xie
Co-construction Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases by Henan & Education Ministry of People’s Republic of China, Henan University of Chinese Medicine
Wei Zhang
Department of Respiratory Disease, Shanghai Shuguang Hospital, Shanghai University of Chinese Medicine
Chengjun Ban
Department of Respiratory Disease, Dongzhimen Hospital of Beijing University of Traditional Chinese Medicine
Jihong Feng
Department of Respiratory Disease, The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Lei Wu
Department of Respiratory Disease, Hebei Province Hospital of Traditional Chinese Medicine
Xuechao Lu
Department of Respiratory Disease, Hiser Medical Center of Qingdao
Limin Zhao
Department of Respiratory Disease, Henan Provincial People’s Hospital
Yong Meng
Department of Respiratory Disease, Henan Province Hospital of Traditional Chinese Medicine
Miao Zhou
Department of Respiratory Disease, The Third Affiliated Hospital of Henan University of Chinese Medicine
Yong He
Department of Respiratory Disease, Zhengzhou Hospital of Traditional Chinese Medicine
Weixian Luo
Department of Traditional Chinese Medicine, Zhengzhou First People’s Hospital
Abstract Background and rationale Idiopathic pulmonary fibrosis is a critical disease with a poor prognosis. Although different studies have been conducted for the treatment of idiopathic pulmonary fibrosis, limited treatments are available. Jin-shui Huan-xian granule (JHG), which is a Chinese medicine herbal compound, has shown promising efficacy in reducing frequencies of acute exacerbations, improving exercise capacity the quality of life of patients with idiopathic pulmonary fibrosis. This study is to evaluate the efficacy and safety of JHG for IPF. 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 the experimental group and the control group will be given JHG and JHG placebo, respectively. Outcome measures including acute exacerbations, pulmonary function, dyspnea, exercise capacity, and quality of life will be evaluated in this study. Discussion Based on our previous study, it is hypothesized that JHG will reduce acute exacerbations; improve exercise capacity, pulmonary function, and quality of life; and delay the disease progression-free. High-level evidence-based support for TCM in IPF will also be obtained in this study. Trial registration ClinicalTrials.gov NCT04187690. Register on December 11, 2019
