REspiratory diSEAse cohoRt Studies of CHinese Medicine for Interstitial Lung Disease (RESEARCH-ILD)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- All-cause mortality
研究概览
简要总结
This study is a traditional Chinese medicine cohort for interstitial lung disease（ILD） in China, including at least 5000 patients with ILD and followed up for at least 5 years. The aim is to focus on the demographic characteristics, clinical features, disease occurrence and development characteristics, TCM syndrome evolution patterns, and clinical efficacy of TCM treatment for ILD in the real world.
详细描述
This study focuses on ILD patients and adopts a prospective cohort study design, with traditional Chinese medicine treatment as the exposure factor. The subjects are divided into a traditional Chinese medicine cohort and a non traditional Chinese medicine cohort, with demographic characteristics, mortality rate, lung transplant rate, annual acute exacerbation frequency, traditional Chinese medicine syndrome, 6MWT, lung function, dyspnea score, quality of life, and other observation indicators. Follow up for at least 5 years will be conducted, and at least 5000 ILD patients will be included, focusing on the demographic characteristics, clinical characteristics, disease occurrence and development characteristics, traditional Chinese medicine syndrome evolution rules, and clinical efficacy of traditional Chinese medicine treatment for ILD in the real world.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet the diagnosis of ILD;
- •Age≥18 years old;
- •Ability to provide independent informed consent.
排除标准
- •Patients with acute ILD caused by known reasons, but the lesions disappear within 2 weeks after treatment. Example: Interstitial pneumonia caused by infections such as mycoplasma/virus, and those who recover after treatment are excluded.
结局指标
主要结局
All-cause mortality
时间窗: up to week 13, 26, 39, 52, 65, 78 ,91 and 104 weeks.
The all-cause mortality will be recorded.
Lung transplantation
时间窗: Up to week 13, 26, 39, 52, 65, 78 ,91 and 104 weeks.
The lung transplantation will be calculated in each cohort at the end of the trial.
次要结局
- Pulse Oxygen Saturation（SPO2）(Change from baseline SPO2 at week 13, 26, 39, 52, 65, 78, 91 and 104.)
- Frequencies of acute exacerbations (AEs)(The frequencies of acute exacerbations at weeks 13, 26, 39, 52, 65, 78, 91 and 104.)
- Clinical symptoms and Signs(Change from baseline clinical symptoms and signs up at week 13, 26, 39, 52, 65, 78, 91 and 104 weeks.)
- St. George's respiratory questionnaire (SGRQ) total scores(Change from baseline SGRQ total scores at week 13, 26, 39, 52, 65, 78, 91 and 104.)
- Traditional Chinese medicine syndromes(The traditional Chinese medicine syndromes at weeks 13, 26, 39, 52, 65, 78 ,91 and 104.s.)
- Pulmonary function(Change from baseline FVC, FVC%, DLco and DLco% at week 26, 52, 78 and 104.)
- Proportion of progressive-free survival(The Proportion of progressive-free survival at weeks 13, 26, 39, 52, 65, 78, 91 and 104.)
- 6 Six Minute Walk Distance(6MWD)(Change from baseline 6MWD at week 13, 26, 39, 52, 65, 78, 91 and 104.)
- A Tool to Assess Quality of life in IPF(ATAQ-IPF) total scores(Change from baseline ATAQ-IPF total scores at week 13, 26, 39, 52, 65, 78, 91 and 104.)
- Imaging findings(Change from baseline Imaging findings at week 13, 26, 39, 52, 65, 78, 91 and 104.)