Effects of Traditional Chinese Medicine on AECOPD Patients: A Multi-center, Randomized, Double-blind, Controlled Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 378
- 主要终点
- COPD Assessment Test(CAT)
研究概览
简要总结
This is a multi-center, randomized, double-blind, controlled trial to compare the efficacy of two therapies for patients with AECOPD. 378 subjects will be randomly assigned to one therapies (conventional drug, and the combination of conventional drug and TCM) for 14 days treatment. After the treatment period, subjects in two arms will be followed up for 4 weeks. The primary outcomes will include COPD Assessment Test (CAT), and secondary outcomes include treatment failure rate, treatment success rate, hospitalization time, hospital admission rate, endotracheal intubation rate, mortality and quality of life (COPD-PRO, SF-36).
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 moderate to very severe AECOPD
- •Age between 40 and 80 years
- •Syndrome differentiation meets criteria of syndrome of external cold and internal fluid,syndrome of phlegm-heat congesting lung,or syndrome of phlegm-damp amassing in lung
- •Without participations in other interventional trials in the previous one month
- •With the informed consent signed
排除标准
- •Pregnant and lactating women
- •Dementia, mental disorders and reluctant partners
- •Complicated with heart failure (NYHA Class IV), or Serious cardiac arrhythmias, or unstable hemodynamics
- •Current respiratory disorders other than COPD (e.g., bronchiectasis, active tuberculosis, pneumothorax, Pleural effusion, pulmonary thromboembolic, or Neuromuscular diseases affect respiratory movement function)
- •Combined tumor
- •Treated outside the hospital for more than 7 days
- •Need to carry out invasive mechanical ventilation respiratory failure
- •Complicated with serious hepatic and renal diseases (liver cirrhosis, portal hypertension, bleeding of varicose veins, dialysis, or renal transplantation)
- •Bedridden for various reasons
- •Allergic to the used medicine
研究组 & 干预措施
TCM plus conventional drug
The experimental group will receive three type of TCM in addition conventional drug according to 2017 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Treatment Guidelines for AECOPD.
干预措施: TCM and conventional drug (Drug)
TCM placebo plus conventional drug
The control group will receive three type of placebo TCM in addition conventional drug according to 2017 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Treatment Guidelines for AECOPD.
干预措施: TCM placebo and conventional drug (Drug)
结局指标
主要结局
COPD Assessment Test(CAT)
时间窗: Change from baseline CAT score at day 0, 14 of the treatment phase, at day 14, 28 of the follow-up phase.
Using COPD Assessment Test ( CAT) to asses the impact of AECOPD on a person's life, and how this changes over time.
次要结局
- Treatment failure rate(The numbers of treatment failure at day 14 of the treatment phase.)
- Treatment success rate(The numbers of treatment success at day 14 of the treatment phase.)
- Length of hospital stays(The length hospital stays in 14 Days of the treatment phase)
- Readmission due to AECOPD(The numbers of readmission due to AECOPD in 28 Days of the followup phase.)
- Mortality(The numbers of mortality at day 14 of the treatment phase and day 28 of the follow-up phase.)
- Intubation rate(The numbers of intubation at day 4,7,10，14 of the treatment phase, at day 14, 28 of the follow-up phase.)
- Dyspnea(Change from Baseline in the mMRC at day 0, 4, 7, 10,14 of the treatment phase, at day 14, 28 of the follow-up phase.)
- SF-36(Change from Baseline in the SF-36 at day 0,14 of the treatment phase, at day 14, 28 of the follow-up phase.)
- COPD-PRO(Change from Baseline in the COPD-PRO at day 0,14 of the treatment phase, at day 14, 28 of the follow-up phase.)