REspiratory diSEAse cohoRt Studies of CHinese Medicine for Asthma (RESEARCH- Asthma)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,508
- 试验地点
- 1
- 主要终点
- Asthma control rate
研究概览
简要总结
The purpose of this study is to define the standard use of TCM treatment regimen as the TCM cohort group and the non-TCM cohort group of those who use conventional Western medicine treatment without the standard TCM treatment regimen through a multi-center, large-sample prospective cohort study design. To evaluate the clinical efficacy and safety of TCM treatment regimens in the treatment of bronchial asthma, and to provide high-quality evidence for the promotion and application of TCM syndrome differentiation treatment in bronchial asthma.
详细描述
Bronchial asthma is characterized by chronic inflammation of the airways, which is often recurrent, long-lasting and difficult to cure. Clinical studies have confirmed that the clinical symptoms and quality of life of asthma patients have been significantly improved after TCM intervention. However, most of the current clinical research methods on asthma are small-sample and RCT studies, resulting in insufficient demonstration of efficacy, and there is an urgent need to carry out multi-center, large-sample, high-quality real-world studies in order to obtain higher quality evidence-based medical evidence.
This is a multi-center, large-sample prospective cohort study, which will evaluate the clinical efficacy and safety of TCM treatment regimens in the treatment of bronchial asthma, and provide high-quality evidence for the promotion and application of TCM syndrome differentiation therapy in bronchial asthma. The cohort study will enroll 1508 patients, and the standard use of TCM treatment regimen will be set as the TCM cohort group, and those who will use the conventional treatment of Western medicine but not the standard TCM treatment regimen will be the non-TCM cohort group. The asthma control rate was the main outcome index, and the asthma control questionnaire (ACQ), asthma quality of life score (AQLQ), clinical symptom and sign score, lung function, exhaled nitric oxide, induced sputum inflammation phenotype, glucocorticoid dose, and fast-acting β2 agonist dose were the secondary outcome indicators. Follow-up was conducted every 3 months for 1 year.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet the diagnosis of bronchial asthma;
- •Age 18~80 years old;
- •Have not participated in other clinical studies within 1 month before enrollment;
- •Voluntarily participate in the study and sign the informed consent form.
排除标准
- •Patients with respiratory failure and mechanical ventilation during acute asthma exacerbation;
- •Delirium, impaired consciousness, dementia, and various mental illnesses;
- •Patients with other lung diseases such as COPD, lung abscess, cystic fibrosis, bronchiectasis, etc., and severe liver and kidney diseases;
- •Patients with neuromuscular diseases that affect respiratory motor function and are unable to complete the six-minute walk test;
- •Pregnant and lactating patients;
- •Those who are participating in other clinical trials.
结局指标
主要结局
Asthma control rate
时间窗: The follow-up period was followed up every 3 months for 1 year.
According to the composite indicators such as symptoms, medication and pulmonary function test results, the clinical control level of asthma was divided into complete control, partial control and uncontrolled, and the asthma control rate of patients was evaluated according to the clinical control level of asthma.
次要结局
- Asthma exacerbation severity(The follow-up period was followed up every 3 months for 1 year.)
- Depression Self-Rating Scale (SDS)(The follow-up period was followed up every 3 months for 1 year.)
- Anxiety Self-Assessment Form (SAS)(The follow-up period was followed up every 3 months for 1 year.)
- Exhaled nitric oxide (FeNO)(The follow-up period was followed up every 3 months for 1 year.)
- Number of exacerbations(The follow-up period was followed up every 3 months for 1 year.)
- Change in severity of chronic persistent disease(The follow-up period was followed up every 3 months for 1 year.)
- Asthma Control Test (ACT) score(The follow-up period was followed up every 3 months for 1 year.)
- Asthma Control Questionnaire (ACQ)(The follow-up period was followed up every 3 months for 1 year.)
- The dose used by glucocorticoids(The follow-up period was followed up every 3 months for 1 year.)
- Pulmonary function(The follow-up period was followed up every 3 months for 1 year.)
- Rapid-acting beta2 agonists use drugs and doses(The follow-up period was followed up every 3 months for 1 year.)
- Asthma Quality of Life Score (AQLQ)(The follow-up period was followed up every 3 months for 1 year.)