Efficacy evaluation of Jinshui Huanxian Formula in delaying lung function decline in idiopathic pulmonary fibrosis: a clinical study protocol for a multicenter, randomized, double-Blind, placebo-controlled trial (Preprint)

BACKGROUND Idiopathic pulmonary fibrosis (IPF) is a progressive, refractory disease characterized by limited treatment options and poor prognosis, underscoring the need for further research into prevention and treatment strategies. Traditional Chinese medicine (TCM) demonstrates potential efficacy in preventing and treating IPF; however, significant challenges persist, such as accelerated lung function deterioration and recurrent acute exacerbations. While preliminary clinical studies on TCM for IPF have been reported, robust, high-quality evidence remains insufficient to support definitive conclusions. OBJECTIVE This study focuses on patients with clinically stable IPF, for whom current therapeutic options are limited. It addresses key clinical issues, including accelerated decline in lung function and frequent acute exacerbations, with the primary objective of slowing the annual rate of lung function decline and reducing the incidence of acute exacerbations. The study complies with international clinical research standards by conducting a large-scale, multicenter, randomized, double-blind, placebo-controlled clinical trial. The primary objectives are to establish a treatment regimen using Jinshui Huanxian Formula to slow the rate of lung function decline in IPF, obtain high-quality evidence-based data, integrate it into clinical guidelines, and promote its clinical application. METHODS This study employed a randomized, double-blind, placebo-controlled trial design, involving 384 patients with IPF. In addition to guideline-based Western medical treatment, the experimental group received Jinshui Huanxian Formula (granules), while the control group received a placebo. Treatment lasted for 52 weeks, with FVC as the primary outcome measure and acute exacerbations, mortality, exercise tolerance, imaging, quality of life, and dyspnea scores as secondary outcome measures. The clinical efficacy of Jinshui Huanxian Formula in slowing the decline in lung function in IPF was evaluated. RESULTS In IPF patients, lung function (FVC) declines rapidly at a rate of 150–230 ml per year, which is 5–10 times faster than in healthy individuals. A 1% decline in lung function results in a reduction of 60 steps per day and is strongly correlated with mortality risk. This study, conducted through a multicenter trial of Jinshui Huanxian Formula, aims to slow the annual decline in lung function by more than 10%, significantly improving prognosis and reducing the social burden. CONCLUSIONS Jinshui Huanxian Formula has been demonstrated to improve lung function and clinical symptoms in IPF patients, reduce the incidence of acute exacerbations, and enhance quality of life . CLINICALTRIAL NCT06914713, Last modified registration date: May 16, 2025