Efficacy and Safety of Jin-shui Huan-xian Granule in the Treatment of IPF
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 312
- 试验地点
- 1
- 主要终点
- Frequencies of acute exacerbations (AEs)
研究概览
简要总结
This study is to evaluate the efficacy and safety of Jin-shui Huan-xian granule for idiopathic pulmonary fibrosis (IPF), establish the treatment scheme, and obtain the high quality clinical evidences.
详细描述
Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive and ultimately fatal interstitial lung disease. With worsened dyspnea and an increasing loss of pulmonary function, IPF patients will have very poor quality of life. It has also brought an increasing social-economic burden. Researches show that pirfenidone and nintedanib could be effective to IPF, which were also recommended by the guideline. However, the application has been limited by side effects and high prices. It is urgent to develop other effective treatments and strategies to manage IPF. The investigators' previous studies shown that Jin-shui Huan-xian granule could be effective to IPF.
This is a multicerter, randomized, double-blind, placebo-controlled trial to assess the efficacy of Jin-shui Huan-xian granule in reducinig the acute exacerbations, improving exercise capacity, and delaying the disease progression for IPF. After a 2-week wash-out period, 312 patients will be randomly assigned into treatment or control group for 52-week treatment. The primary outcomes are frequencies of acute exacerbation, 6-minute walking test, and percentage of patients with progression-free survival. The secondary outcomes include pulmonary function, all-cause mortality, clinical symptoms, dyspnea score, and quality of life. Safety will also be evaluated.
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
- •A confirmed diagnosis stable IPF.
- •Age ranges from 40 years to 85 years.
- •TCM Syndrome differentiation meets criteria of pattern of Lung Qi deficiency, yin deficiency and inter heat, and lung-kidney qi deficiency.
- •Without participanting in any other trial.
- •With signed informed consent.
排除标准
- •Pregnant, nursing or may become pregnant women.
- •Patients with unconscious, dementia or mental disorders.
- •Patients with severe cardiac dysfunction.
- •Patients with severe liver and kidney diseases.
- •Patients with asthma, bronchiectasis, active pulmonary tuberculosis, pulmonary embolism, chronic obstructive pulmonary disease, chronic respiratory failure or other severe respiratory diseases.
- •Patients with tumor after resection, radiotherapy or chemotherapy in the past 5 years.
- •Patients with severe neuromuscular disorders, severe arthritis or severe peripheral vascular diseases.
- •Patients with long-term bedridden.
- •Patients who are allergic to any of the treatment drugs.
研究组 & 干预措施
Jin-shui Huan-xian granule
Participants in this arm will be given Jin-shui Huan-xian granule.
干预措施: Jin-shui Huan-xian granule (Drug)
Jin-shui Huan-xian granule placebo
Participants in this arm will be given Jin-shui Huan-xian granule placebo.
干预措施: Jin-shui Huan-xian granule placebo (Drug)
结局指标
主要结局
Frequencies of acute exacerbations (AEs)
时间窗: up to 52 weeks.
It will be assessed by frequencies of AEIPF-related hospitalizations.
Six-minute walking distance(6MWD)
时间窗: Change from baseline 6MWD at week 13, 26, 39 and 52
6MWD will be applied to evaluate the exercise capacity. The higher values indicate the better exercise capacity.
Proportion of progressive-free survival
时间窗: up to week 13, 26, 39 and 52.
Endpoints of Progressive-free survival include FVC decreased by 10% compared with baseline, or DLCO% decreased by 15%, or death or lung transplantation.
次要结局
- All-cause mortality(up to 52 weeks.)
- Clinical symptoms and Signs(Change from baseline clinical symptoms assessment questionnaire scores at week 13, 26, 39 and 52.)
- A Tool to Assess Quality of life in IPF(ATAQ-IPF)(Change from baseline ATAQ scores at week 13, 26, 39 and 52.)
- Pulmonary function(Change from baseline FVC and DLco% at week 26 and 52.)
- Dyspnea(Change from baseline mMRC scores at week 13, 26, 39 and 52.)
- 36-item short-form health survey (SF-36) total scores(Change from baseline SF-36 scores at week 13, 26, 39 and 52.)
- COPD assessment test (CAT)(Change from baseline CAT scores at week 13, 26, 39 and 52.)
- St. George's respiratory questionnaire (SGRQ) total scores(Change from baseline SGRQ scores at week 13, 26, 39 and 52.)