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

Henan University of Traditional Chinese Medicine

Status: Not yet enrolling

Conditions: Idiopathic Pulmonary Fibrosis(IPF)

Treatments: Drug: Jin-shui Huan-xian granule placebo; Drug: Jin-shui Huan-xian granule

Study type: Interventional

Funder types: Other

Identifiers

NCT06914713

CM for IPF

Details and patient eligibility

About

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）

Full 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.

Enrollment: 384 estimated patients

Sex: All

Ages: 40 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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384 participants in 2 patient groups, including a placebo group

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

Experimental group

Description:

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 ".

Treatment:

Drug: Jin-shui Huan-xian granule

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

Placebo Comparator group

Description:

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 ".

Treatment:

Drug: Jin-shui Huan-xian granule placebo