Efficacy Evaluation of Jin-shui Huan-xian Formula in Retarding the Decline of Pulmonary Function in IPF
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 384
- 试验地点
- 1
- 主要终点
- Forced vital capacity (FVC)
研究概览
简要总结
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）
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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 ".
干预措施: Jin-shui Huan-xian granule (Drug)
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 ".
干预措施: Jin-shui Huan-xian granule placebo (Drug)
结局指标
主要结局
Forced vital capacity (FVC)
时间窗: The change in absolute FVC value before treatment and at 52 weeks of treatment
FVC will be used to assess pulmonary function.
次要结局
- Frequency of acute exacerbation(Up to week 52)
- The time of the first acute exacerbation(Up to week 52.)
- Frequency of acute exacerbations resulting in hospitalization(Up to week 52)
- Frequency of acute exacerbations resulting in ICU admission(Up to week 52)
- Annual acute exacerbation rate(Up to week 52)
- Annual hospitalization rate due to acute exacerbation(Up to week 52)
- Annual rate of ICU admission due to acute exacerbation(Up to week 52.)
- Diffusing Capacity of Carbon Monoxide（DLCO）(Change from baseline DLCO at week 13, 26, 39 and 52.)
- Percent of Diffusing Capacity of Carbon Monoxide（DLCO%）(Change from baseline DLCO% at week 13, 26, 39 and 52.)
- Percent of Forced Vital Capacity（FVC%）(Change from baseline FVC%at week 13, 26, 39 and 52.)
- Alveolar ventilation（VA）(Change from baseline VA at week 13, 26, 39 and 52.)
- .Diffusion capacity for carbon monoxide per liter of alveolar volume（DLCO/VA）(Change from baseline DLCO/VA at week 13, 26, 39 and 52.)
- All-cause mortality rate(Up to week 52.)
- Mortality rate due to acute exacerbation(Up to week 52.)
- Progression-Free Survival（PFS）(Up to week 13, 26, 39 and 52.)
- Six Minute Walk Test (6MWT)(Change from baseline 6MWT at week 13, 26, 39 and 52.)
- Imaging findings(Up to week 26, 52.)
- A Tool to Assess Quality of life (ATAQ-IPF)(Change from baseline ATAQ-IPF scores at week 13, 26, 39 and 52.)
- Idiopathic pulmonary fibrosis patient reported outcomes (IPF-PRO)(Change from baseline SGRQ scores at week 13, 26, 39 and 52.)
- Dyspnea(Change from baseline CAT scores at week 13, 26, 39 and 52.)
- Cough Visual analog scale(VAS)(Change from baseline CAT scores at week 13, 26, 39 and 52.)
- Clinical symptoms and Signs(Change from baseline clinical symptoms and signs up at week 13, 26, 39 and 52.)
- Krebs Von den Lungen-6 (KL-6)(Change from baseline KL-6 level at week 13, 26, 39 and 52.)
- Interleukin-6 (IL-6)(Change from baseline IL-6 level at week 13, 26, 39 and 52.)
- Ferritin(Change from baseline Ferritin level at week 13, 26, 39 and 52.)
- Immunoglobulin(Change from baseline immunoglobulins level at week 13, 26, 39 and 52.)
- T, B and NK lymphocyte subsets(Change from baseline T, B and NK lymphocyte subsets level at week 13, 26, 39 and 52.)