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NCT06914713

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

Sponsor: Henan University of Traditional Chinese Medicine

View on ClinicalTrials.gov

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）

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

Key Details

Gender

All

Age Range

40 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

384

Start Date

2025-08-01

Completion Date

2028-11-30

Last Updated

2025-08-05

Healthy Volunteers

Conditions

Idiopathic Pulmonary Fibrosis(IPF)

Interventions

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.

Inclusion Criteria: 1. Patients who meet the diagnostic criteria for IPF. 2. Pulmonary function: The percentage of forced vital capacity (FVC) to the predicted value is ≥ 50%; and the percentage of the diffusing capacity of the lung for carbon monoxide (DLCO) to the predicted value is ≥ 30%. 3. Patients who meet the syndrome - differentiation criteria for lung - qi deficiency syndrome, lung - and - kidney qi deficiency syndrome, etc. 4. Aged between 40 and 85 years old. 5. Patients who voluntarily accept the treatment and sign the informed consent Exclusion Criteria: 1. Patients in the acute exacerbation phase of IPF. 2. Patients complicated with other pulmonary diseases such as chronic obstructive pulmonary disease (COPD), lung cancer, active pulmonary tuberculosis, bronchiectasis, and pulmonary embolism. 3. Patients with severe joint, peripheral nerve, and peripheral vascular diseases that affect limb movement and who are bed - ridden for a long time and cannot complete the six - minute walk test. 4. Patients complicated with severe cardiovascular and cerebrovascular diseases (malignant arrhythmia, unstable angina pectoris, acute myocardial infarction, heart function grade 3 or above, stroke, cerebral hemorrhage, etc.). 5. Patients complicated with liver diseases such as cirrhosis or secondary portal hypertension, bleeding caused by esophageal and gastric varices, patients with kidney diseases requiring dialysis or kidney transplantation, or patients with abnormal liver and kidney functions (ALT, AST, and BUN are 1.5 times higher than the upper limit of the normal range, and blood Cr is higher than the upper limit of the normal range). 6. Patients with unclear consciousness, various mental illnesses, etc., who cannot communicate normally. 7. Pregnant or lactating women and patients with a recent plan for pregnancy. 8. Patients who have participated in other clinical trials within 1 month before enrollment. 9. Patients known to be allergic to any of the test medications and their components.

Locations (1)

the First Affiliated Hospital of Henan University of Chinese Medicine

Zhengzhou, Henan, China