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, 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

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.

Keywords: Idiopathic pulmonary fibrosis; Jin-shui Huan-xian granule; Randomized controlled trial; Study protocol; Traditional Chinese medicine.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
The whole flow chart for this study
Fig. 2
Fig. 2
Research flow chart for every participants in the study

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