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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）
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Jin-shui Huan-xian granule in addition to the guideline - directed treatment. | Experimental | 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 ". |
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| Jin-shui Huan-xian granule placebo in addition to the guideline - directed treatment. | Placebo Comparator | 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 ". |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jin-shui Huan-xian granule | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming-Hang Wang, Ph.D | Contact | +8618638392188 | wmh107hn@163.com | |
| Xue-qing Yu, Ph.D | Contact | +8613525518843 | yxqshi@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital of Henan University of Chinese Medicine | Zhengzhou | Henan | 450056 | China |
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Jin-shui Huan-xian granule placebo | 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. |
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| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |