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

NCT ID: NCT06914713

Last Updated: 2025-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

384 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2028-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Idiopathic Pulmonary Fibrosis(IPF)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Jin-shui Huan-xian granule in addition to the guideline - directed treatment.

The 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 ".

Group Type EXPERIMENTAL

Jin-shui Huan-xian granule

Intervention Type DRUG

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 in addition to the guideline - directed treatment.

The 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 ".

Group Type PLACEBO_COMPARATOR

Jin-shui Huan-xian granule placebo

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Jin-shui Huan-xian Granules

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Henan University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

the First Affiliated Hospital of Henan University of Chinese Medicine

Zhengzhou, Henan, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ming-Hang Wang, Ph.D

Role: CONTACT

+8618638392188

Xue-qing Yu, Ph.D

Role: CONTACT

+8613525518843

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ming-Hang Wang, Ph.D

Role: primary

+8618638392188

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CM for IPF

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.