NCT06914713

Jin-shui Huan-xian Formula for Retarding the Decline of Pulmonary Function in IPF

Efficacy Evaluation of Jin-shui Huan-xian Formula in Retarding the Decline of Pulmonary Function in IPF

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 384 (estimated)
• Sponsor: Henan University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study is to evaluate the clinical efficacy and safety of Jin-shui Huan-xian Formula in retarding the decline of pulmonary function in IPF, generate high - quality clinical evidence, and establish a treatment plan of Jin-shui Huan-xian Formula for retarding the decline of pulmonary function in Idiopathic Pulmonary Fibrosis（IPF）

Detailed description

The study took 384 IPF patients as the research objects and adopted a randomized, double - blind, placebo - controlled trial design. The patients were randomly divided into an experimental group and a control group. On the basis of guideline - guided treatment, the experimental group was given Jin-shui Huan-xian Formula, and the control group was given a placebo of Jin-shui Huan-xian Formula. The treatment lasted for 52 weeks. Pulmonary function (FVC) was set as the primary outcome indicator, and acute exacerbation, pulmonary function (DLCO, DLCO%, etc.), exercise endurance, quality of life, etc. were set as secondary outcome indicators. Blood routine, urine routine, liver function, renal function, electrocardiogram, etc. were set as safety indicators. The clinical efficacy and safety of Jin-shui Huan-xian Formula in retarding the decline of pulmonary function in IPF were evaluated to generate high - quality clinical evidence and establish a treatment plan of Jin-shui Huan-xian Formula for retarding the decline of pulmonary function in IPF.

Conditions

• Idiopathic Pulmonary Fibrosis(IPF)

Interventions

Type	Name	Description
DRUG	Jin-shui Huan-xian granule	Jin-shui Huan-xian Granules: on the basis of treatment guided by "Idiopathic Pulmonary Fibrosis (an Update) and Progressive Pulmonary Fibrosis in Adults: An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline ", the experimental group was given Jin-shui Huan-xian Granules for treatment. The granules were taken orally, 1 dose per day, twice a day, and the continuous administration lasted for 52 weeks.
DRUG	Jin-shui Huan-xian granule placebo	Jin-shui Huan-xian granule placebo: on the basis of treatment guided by "Idiopathic Pulmonary Fibrosis (an Update) and Progressive Pulmonary Fibrosis in Adults: An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline ", the experimental group was given Jin-shui Huan-xian Granules placebo for treatment. The granules were taken orally, 1 dose per day, twice a day, and the continuous administration lasted for 52 weeks.The Jin-shui Huan-xian granules and their placebo are identical in appearance, weight, color and smell.

Timeline

• Start date: 2025-08-01
• Primary completion: 2028-06-30
• Completion: 2028-11-30
• First posted: 2025-04-06
• Last updated: 2025-08-05

Locations

1 site across 1 country: China