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
1 other identifier
interventional
384
1 country
1
Brief 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）
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2025
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2025
CompletedFirst Posted
Study publicly available on registry
April 6, 2025
CompletedStudy Start
First participant enrolled
August 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2028
August 5, 2025
March 1, 2025
2.9 years
March 31, 2025
July 31, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Forced vital capacity (FVC)
FVC will be used to assess pulmonary function.
The change in absolute FVC value before treatment and at 52 weeks of treatment
Secondary Outcomes (27)
The time of the first acute exacerbation
Up to week 52.
Frequency of acute exacerbation
Up to week 52
Frequency of acute exacerbations resulting in hospitalization
Up to week 52
Frequency of acute exacerbations resulting in ICU admission
Up to week 52
Annual acute exacerbation rate
Up to week 52
- +22 more secondary outcomes
Study Arms (2)
Jin-shui Huan-xian granule in addition to the guideline - directed treatment.
EXPERIMENTALThe experimental group was given Jin-shui Huan-xian Formula in addition to the treatment guided by the guideline "Idiopathic Pulmonary Fibrosis (an Update) and Progressive Pulmonary Fibrosis in Adults: An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline ".
Jin-shui Huan-xian granule placebo in addition to the guideline - directed treatment.
PLACEBO COMPARATORThe experimental group was given Jin-shui Huan-xian granule placebo in addition to the treatment guided by the guideline"Idiopathic Pulmonary Fibrosis (an Update) and Progressive Pulmonary Fibrosis in Adults: An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline ".
Interventions
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: 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.
Eligibility Criteria
You may qualify if:
- Patients who meet the diagnostic criteria for IPF.
- 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%.
- Patients who meet the syndrome - differentiation criteria for lung - qi deficiency syndrome, lung - and - kidney qi deficiency syndrome, etc.
- Aged between 40 and 85 years old.
- Patients who voluntarily accept the treatment and sign the informed consent
You may not qualify if:
- Patients in the acute exacerbation phase of IPF.
- Patients complicated with other pulmonary diseases such as chronic obstructive pulmonary disease (COPD), lung cancer, active pulmonary tuberculosis, bronchiectasis, and pulmonary embolism.
- 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.
- 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.).
- 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).
- Patients with unclear consciousness, various mental illnesses, etc., who cannot communicate normally.
- Pregnant or lactating women and patients with a recent plan for pregnancy.
- Patients who have participated in other clinical trials within 1 month before enrollment.
- Patients known to be allergic to any of the test medications and their components.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
the First Affiliated Hospital of Henan University of Chinese Medicine
Zhengzhou, Henan, 450056, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2025
First Posted
April 6, 2025
Study Start
August 1, 2025
Primary Completion (Estimated)
June 30, 2028
Study Completion (Estimated)
November 30, 2028
Last Updated
August 5, 2025
Record last verified: 2025-03