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

Official title

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

Overview

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

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.

Interventions

• 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.
• 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, w

Primary outcome measures

• Forced vital capacity (FVC) [Time frame: The change in absolute FVC value before treatment and at 52 weeks of treatment]

Secondary outcome measures (12)

• The time of the first acute exacerbation [Time frame: Up to week 52.]
• Frequency of acute exacerbation [Time frame: Up to week 52]
• Frequency of acute exacerbations resulting in hospitalization [Time frame: Up to week 52]
• Frequency of acute exacerbations resulting in ICU admission [Time frame: Up to week 52]
• Annual acute exacerbation rate [Time frame: Up to week 52]
• Annual hospitalization rate due to acute exacerbation [Time frame: Up to week 52]
• Annual rate of ICU admission due to acute exacerbation [Time frame: Up to week 52.]
• Diffusing Capacity of Carbon Monoxide（DLCO） [Time frame: Change from baseline DLCO at week 13, 26, 39 and 52.]
• Percent of Diffusing Capacity of Carbon Monoxide（DLCO%） [Time frame: Change from baseline DLCO% at week 13, 26, 39 and 52.]
• Percent of Forced Vital Capacity（FVC%） [Time frame: Change from baseline FVC%at week 13, 26, 39 and 52.]
• Alveolar ventilation（VA） [Time frame: Change from baseline VA at week 13, 26, 39 and 52.]
• .Diffusion capacity for carbon monoxide per liter of alveolar volume（DLCO/VA） [Time frame: Change from baseline DLCO/VA at week 13, 26, 39 and 52.]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 1 center

• the First Affiliated Hospital of Henan University of Chinese Medicine — Zhengzhou

Identifiers

NCT: NCT06914713 · CM for IPF

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗