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Clinical Trials in China / NCT06914713
Starting soon Not applicable

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

NCT06914713 · tracked via the Priya Life Science China tracker
Sponsor
Henan University of Traditional Chinese Medicine
Phase
Not applicable
Started
2025-08-01
Last updated
2025-08-05

Condition(s) studied

Idiopathic Pulmonary Fibrosis(IPF)

Investigational drug(s) / intervention(s)

Jin-shui Huan-xian granuleJin-shui Huan-xian granule placebo

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.

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.

Study 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)

Eligibility

Sex
ALL
Min age
40 Years
Max age
85 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
the First Affiliated Hospital of Henan University of Chinese Medicine Zhengzhou Henan

More Henan University of Traditional Chinese Medicine trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06914713 on ClinicalTrials.gov ↗ ← All trials in China