Clinical trial NCT06914713: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Idiopathic Pulmonary Fibrosis(IPF)
Keywords: Idiopathic Pulmonary Fibrosis
traditional Chinese medicine
randomized controlled trial
pulmonary function
Lead sponsor: Henan University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 384
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Forced vital capacity (FVC)
timeFrame: The change in absolute FVC value before treatment and at 52 weeks of treatment
Secondary outcomes:
measure: The time of the first acute exacerbation
timeFrame: Up to week 52.
measure: Frequency of acute exacerbation
timeFrame: Up to week 52
measure: Frequency of acute exacerbations resulting in hospitalization
timeFrame: Up to week 52
measure: Frequency of acute exacerbations resulting in ICU admission
timeFrame: Up to week 52
measure: Annual acute exacerbation rate
timeFrame: Up to week 52
measure: Annual hospitalization rate due to acute exacerbation
timeFrame: Up to week 52
measure: Annual rate of ICU admission due to acute exacerbation
timeFrame: Up to week 52.
measure: Diffusing Capacity of Carbon Monoxide（DLCO）
timeFrame: Change from baseline DLCO at week 13, 26, 39 and 52.
measure: Percent of Diffusing Capacity of Carbon Monoxide（DLCO%）
timeFrame: Change from baseline DLCO% at week 13, 26, 39 and 52.
measure: Percent of Forced Vital Capacity（FVC%）
timeFrame: Change from baseline FVC%at week 13, 26, 39 and 52.
measure: Alveolar ventilation（VA）
timeFrame: Change from baseline VA at week 13, 26, 39 and 52.
measure: .Diffusion capacity for carbon monoxide per liter of alveolar volume（DLCO/VA）
timeFrame: Change from baseline DLCO/VA at week 13, 26, 39 and 52.
measure: All-cause mortality rate
timeFrame: Up to week 52.
measure: Mortality rate due to acute exacerbation
timeFrame: Up to week 52.
measure: Progression-Free Survival（PFS）
timeFrame: Up to week 13, 26, 39 and 52.
measure: Six Minute Walk Test (6MWT)
timeFrame: Change from baseline 6MWT at week 13, 26, 39 and 52.
measure: Imaging findings
timeFrame: Up to week 26, 52.
measure: A Tool to Assess Quality of life (ATAQ-IPF)
timeFrame: Change from baseline ATAQ-IPF scores at week 13, 26, 39 and 52.
measure: Idiopathic pulmonary fibrosis patient reported outcomes (IPF-PRO)
timeFrame: Change from baseline SGRQ scores at week 13, 26, 39 and 52.
measure: Dyspnea
timeFrame: Change from baseline CAT scores at week 13, 26, 39 and 52.
measure: Cough Visual analog scale(VAS)
timeFrame: Change from baseline CAT scores at week 13, 26, 39 and 52.
measure: Clinical symptoms and Signs
timeFrame: Change from baseline clinical symptoms and signs up at week 13, 26, 39 and 52.
measure: Krebs Von den Lungen-6 (KL-6)
timeFrame: Change from baseline KL-6 level at week 13, 26, 39 and 52.
measure: Interleukin-6 (IL-6)
timeFrame: Change from baseline IL-6 level at week 13, 26, 39 and 52.
measure: Ferritin
timeFrame: Change from baseline Ferritin level at week 13, 26, 39 and 52.
measure: Immunoglobulin
timeFrame: Change from baseline immunoglobulins level at week 13, 26, 39 and 52.
measure: T, B and NK lymphocyte subsets
timeFrame: Change from baseline T, B and NK lymphocyte subsets level at week 13, 26, 39 and 52.
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: the First Affiliated Hospital of Henan University of Chinese Medicine
state: Henan
Study officials:
References: