Detection and Intervention on Mild/Moderate Chronic Obstructive Pulmonary Disease by Traditional Chinese Medicine Treatment and Application
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 504
- 主要终点
- pulmonary function（FEV1）
研究概览
简要总结
The purpose of this study is evaluate the effects and safety of Traditional Chinese medicine for prevention and management of mild/moderate chronic obstructive pulmonary disease (COPD).
详细描述
This is a multicenter, randomized, double-blind, placebo controlled study to evaluate the effect of Traditional Chinese medicine (TCM) in COPD subjects. Following a 14 day run-in period, approximately 504 subjects will be randomly assigned to double-blind treatment for 52 weeks. After the 52 weeks treatment period, subjects in both treatment arms will follow-up 52 weeks. The primary measure of efficacy is the frequency of exacerbations and spirometric values (e.g. FEV1). Secondary efficacy measures include Dyspnea (MMRC), Quality of life ( CAT,SF-36), Exercise Capacity( 6MWD). Safety will be assessed through the collection of adverse events. There will be a total of 5 study visits ( randomization, and after 13, 26, 39 and 52 weeks of treatment). A follow-up contact for collection of effect and adverse event will be conducted approximately 52 weeks following the last study visit.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A confirmed diagnosis of mild/moderate COPD.
- •Age between 40 and 80 years.
- •Syndrome differentiation belongs to Syndrome of lung-qi deficiency, Syndrome of deficiency of pulmonosplenic qi, Syndrome of insufficiency of QI of the lung and kidney.
- •Without participation in other interventional trials in the previous one month.
- •With the informed consent signed.
排除标准
- •Pregnant or breast-feeding women.
- •Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study .
- •Complicated with severe heart failure (class Ⅳ NYHA heart function) or unstable hemodynamics.
- •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.
- •Use of oral or parenteral corticosteroids before 1 months of Visit 1 .
- •With immunodeficiency.
- •Participating in other trials or allergic to the used medicine.
研究组 & 干预措施
traditional chinese medicine
The experimental group will receive three type of TCM, they are Baofei granule, Bufeijianpi granule and Bufeiyishen granule.
干预措施: Traditional Chinese Medicine (Drug)
placebo
placebo chinese medicine in addition to best care according to clinical guidelines for COPD patients
干预措施: placebo chinese medicine (Drug)
结局指标
主要结局
pulmonary function（FEV1）
时间窗: Change from Baseline in FEV1 at Week 26 and 52 of the treatment phase, Week 26 and 52 of the followup phase
the frequency of exacerbation
时间窗: Change from Baseline in the frequency of exacerbation at Week 26 and 52 of the treatment phase, Week 26 and 52 of the followup phase
次要结局
- Dyspnea(Change from Baseline in MMRC at Week 13, 26, 39 and 52 of the treatment phase, Week 26 and 52 of the followup phase)
- Quality of life(Change from Baseline in CAT and SF-36 at Week 13, 26, 39 and 52 of the treatment phase, Week 26 and 52 of the followup phase)
- 6 Minutes Walking Distance Test ( 6MWD)(Change from Baseline in 6MWD at Week 13, 26, 39 and 52 of the treatment phase, Week 26 and 52 of the followup phase)