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

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）

Study Overview

• Status: Not yet recruiting
• Conditions: Idiopathic Pulmonary Fibrosis(IPF)
• Intervention / Treatment: Drug: Jin-shui Huan-xian granule; Drug: Jin-shui Huan-xian granule placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 384
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xue-qing Yu, Ph.D; Phone Number: +8613525518843; Email: yxqshi@163.com
• Study Contact Backup: Name: Ming-Hang Wang, Ph.D; Phone Number: +8618638392188; Email: wmh107hn@163.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450056
      • the First Affiliated Hospital of Henan University of Chinese Medicine
      • Contact: Ming-Hang Wang, Ph.D; Phone Number: +8618638392188; Email: wmh107hn@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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 ".	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.; Other Names: Jin-shui Huan-xian Granules
Placebo Comparator: 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 ".	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The time of the first acute exacerbation	The time of the patients' first acute exacerbation will be recorded.	Up to week 52.
Frequency of acute exacerbation	Frequency of acute exacerbation will be recorded.	Up to week 52
Frequency of acute exacerbations resulting in hospitalization	Frequency of acute exacerbation resulting in hospitalization will be recorded.	Up to week 52
Frequency of acute exacerbations resulting in ICU admission	Frequency of acute exacerbation resulting in ICU admission will be recorded.	Up to week 52
Annual acute exacerbation rate	The annual acute exacerbation rate will be calculated in each group at the end of the trial.	Up to week 52
Annual hospitalization rate due to acute exacerbation	The Annual hospitalization rate due to acute exacerbation will be calculated in each group at the end of the trial.	Up to week 52
Annual rate of ICU admission due to acute exacerbation	The Annual ICU admission rate due to acute exacerbation will be calculated in each group at the end of the trial.	Up to week 52.
Diffusing Capacity of Carbon Monoxide（DLCO）	DLCO will be used to assess pulmonary function.	Change from baseline DLCO at week 13, 26, 39 and 52.
Percent of Diffusing Capacity of Carbon Monoxide（DLCO%）	DLCO% will be used to assess pulmonary function.	Change from baseline DLCO% at week 13, 26, 39 and 52.
Percent of Forced Vital Capacity（FVC%）	FVC% will be used to assess pulmonary function.	Change from baseline FVC%at week 13, 26, 39 and 52.
Alveolar ventilation（VA）	VA will be used to assess pulmonary function.	Change from baseline VA at week 13, 26, 39 and 52.
.Diffusion capacity for carbon monoxide per liter of alveolar volume（DLCO/VA）	DLCO/VA will be used to assess pulmonary function.	Change from baseline DLCO/VA at week 13, 26, 39 and 52.
All-cause mortality rate	The all-cause mortality rate will be calculated in each group at the end of the trial.	Up to week 52.
Mortality rate due to acute exacerbation	The mortality rate due to acute exacerbation will be calculated in each group at the end of the trial.	Up to week 52.
Progression-Free Survival（PFS）	According to "Idiopathic Pulmonary Fibrosis in Adults (Update) and Progressive Pulmonary Fibrosis: An Official Clinical Practice Guideline of the ATS/ERS/JRS/ALAT ": The time from enrollment to the first meeting of disease progression (at least two of respiratory symptoms, physiological evidence and radiological evidence).	Up to week 13, 26, 39 and 52.
Six Minute Walk Test (6MWT)	6MWT will be applied to evaluate the exercise capacity. The higher values indicate the better exercise capacity.	Change from baseline 6MWT at week 13, 26, 39 and 52.
A Tool to Assess Quality of life (ATAQ-IPF)	ATAQ - IPF is currently a specialized scale for evaluating the quality of life of patients, consisting of 13 dimensions and 74 items, with each item being scored from 1 to 5 points. A higher score indicates a worse condition.	Change from baseline ATAQ-IPF scores at week 13, 26, 39 and 52.
Dyspnea	Dyspnea will be assessed by 22.modified Medical Research Council(mMRC) scores. A score of 0-4 will be given according to the degree of immediate dyspnea. A higher score indicates a worse condition.	Change from baseline CAT scores at week 13, 26, 39 and 52.
Clinical symptoms and Signs	Clinical symptoms and Signs will be evaluated through a scale. The scale includes coughing, expectoration, chest tightness, shortness of breath, wheezin. The Clinical Symptom Rating Scale includes 6 items: cough, expectoration, chest tightness, shortness of breath, wheezing, and cyanosis. Each item has a score of 0-3, totaling 18 points. The higher the score, the worse he patient's condition.	Change from baseline clinical symptoms and signs up at week 13, 26, 39 and 52.
Krebs Von den Lungen-6 (KL-6)	Detect the level of KL-6.	Change from baseline KL-6 level at week 13, 26, 39 and 52.
Interleukin-6 (IL-6)	Detect the level of IL-6.	Change from baseline IL-6 level at week 13, 26, 39 and 52.
Ferritin	Detect the level of Ferritin.	Change from baseline Ferritin level at week 13, 26, 39 and 52.
Immunoglobulin	Detect the level of immunoglobulins	Change from baseline immunoglobulins level at week 13, 26, 39 and 52.
Imaging findings	Changes in chest CT imaging will be assessed before and after JSHX treatment to evaluate its impact on pulmonary fibrosis in IPF patients. High-resolution computed tomography (HRCT) will be used to quantify alterations in lung parenchyma, including ground-glass opacities, reticulation, and honeycombing. Quantitative software-based analysis (e.g., histogram-based texture analysis) may be applied to standardize the evaluation. Radiologists blinded to treatment allocation will independently review the images to ensure objectivity.	Up to week 26, 52.
Idiopathic pulmonary fibrosis patient reported outcomes (IPF-PRO)	IPF-PRO is a scale used to evaluate the quality of life of patients, where patients recall their condition over the past two weeks based on their subjective experience. The evaluation covers four domains: Physiological, Psychological, Environmental, and Satisfaction, comprising 18 items in total. Higher scores indicate worse conditions.	Change from baseline SGRQ scores at week 13, 26, 39 and 52.
Cough Visual analog scale(VAS)	The Cough VAS is a method of quantitatively assessing cough symptoms using the Visual Analogue Scale. The score ranges from 1 to 100, a higher score indicates a worse condition.	Change from baseline CAT scores at week 13, 26, 39 and 52.
T, B and NK lymphocyte subsets	Detect the level of T, B and NK lymphocyte subsets. The common indicators of TBNK lymphocyte subsets and their respective units of measurement are as follows: the total T cells (CD3+), measured in cells per microliter (cells/µL); the helper T cells (CD3+CD4+), measured in cells/µL; the cytotoxic T cells (CD3+CD8+), measured in cells/µL; the B cells (CD19+), measured in cells/µL; the natural killer cells (NK cells, CD16+CD56+, CD3-), measured in cells/µL; and the CD4/CD8 ratio, which is a unitless ratio. These indicators are detected by flow cytometry and can reflect the immune function status of the body.	Change from baseline T, B and NK lymphocyte subsets level at week 13, 26, 39 and 52.

Collaborators and Investigators

• Sponsor: Henan University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): November 30, 2028

Study Registration Dates

• First Submitted: March 31, 2025
• First Submitted That Met QC Criteria: March 31, 2025
• First Posted (Actual): April 6, 2025

Study Record Updates

• Last Update Posted (Actual): August 5, 2025
• Last Update Submitted That Met QC Criteria: July 31, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: randomized controlled trial; pulmonary function; traditional Chinese medicine; Idiopathic Pulmonary Fibrosis
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
• Other Study ID Numbers: CM for IPF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No