Detection and Intervention on Mild/Moderate Chronic Obstructive Pulmonary Disease by Traditional Chinese Medicine Treatment and Application
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 464
- 主要终点
- 6 Minutes Walking Distance Test ( 6MWD)
研究概览
简要总结
The purpose of this study is to compare the exercise capacity and pulmonary function test parameters of Chronic Obstructive Pulmonary Disease (COPD) patients who underwent usual care with and without pulmonary daoyin therapy of China in community.
详细描述
This is a multicenter, randomized, none-blind, controlled study to evaluate the effect of pulmonary daoyin therapy in moderate to very severe COPD subjects. Following a 14 day run-in period, approximately 464 subjects will be randomly assigned to none-blind treatment for 3 months. The primary measure of efficacy is the Exercise Capacity (6MWD) and spirometric values (e.g. FEV1). Secondary efficacy measures include Dyspnea (MMRC), Quality of life (CAT,SF-36), frequency of exacerbations. Safety will be assessed through the collection of adverse events. There will be a total of 4 study visits (randomization, and after 1,2,3 months of treatment).
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
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A confirmed diagnosis of moderate to very severe COPD.
- •Age between 40 and 80 years.
- •Without participation in other interventional trials in the previous one month.
- •With the informed consent signed.
排除标准
- •Patients with poor mobility that can not do the exercise, i.e. wheelchair bound.
- •Pregnant or breast-feeding women.
- •Resting pulmonary artery pressure > 45mmHg.
- •Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study.
- •Patients with severe comorbidities, including acute myocardial infarction and unstable angina pectoris.
- •Patients with post exercise syncope and osteoarthrosis that affect movement.
- •Complicated with severe heart failure (class II to IV NYHA heart function).
- •Complicated with bronchial asthma, bronchiectasis or active tuberculosis;
- •Complicated with obliterative bronchiolitis or diffuse pantothenic bronchiolitis，
- •Complicated with pneumothorax, pleural effusion or pulmonary embolism.
- •Complicated with neuromuscular disorder which affects the respiration.
- •Complicated with tumors .
- •Complicated with serious hepatic and renal diseases.
- •Long periods of bed rest .
- •Participating in other trials or allergic to the used medicine.
结局指标
主要结局
6 Minutes Walking Distance Test ( 6MWD)
时间窗: Change from Baseline in 6MWD at month 3 of the treatment phase
Forced expiratory volume in one second, FEV1
时间窗: Change from Baseline in FEV1 at month 3 of the treatment phase
次要结局
- Modified Medical Research Council (MMRC) scale(Change from Baseline in MMRC at month 1, 2 and 3 months of the treatment phase)
- Quality of life(Change from Baseline in CAT and SF-36 at month 3 of the treatment phase)