Effects of Chinese Medicine on Patients With Severe Acute Exacerbation of COPD：A Multicentre, Randomised, Double-blind, Placebo-parallel Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 468
- 主要终点
- Treatment failure rate
研究概览
简要总结
The purpose of this study was to evaluate the effects of Chinese Medicine on patients with severe AECOPD, and to provide a basis for the establishment of integrated CM and Western medicine diagnosis and treatment scheme for patients with severe AECOPD.
详细描述
Aiming at the key problems such as the lack of high-quality clinical research evidence of Chinese medicine in the prevention and treatment of severe AECOPD, this study adopted a multi-center, randomized, double-blind, placebo-controlled parallel trial design, taking 468 severe AECOPD patients as the research object, to evaluate the clinical efficacy and safety of Chinese medicine combined with western medicine in the treatment of severe AECOPD. To establish an integrated Chinese and western medicine diagnosis and treatment plan to reduce the treatment failure rate of severe AECOPD patients, and to form high-level evidence-based evidence.
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
- Double (Participant, Investigator)
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
- •Patients with severe AECOPD.;
- •Age 40-80 years old;
- •Chinese medicine diagnosis consistent with external cold and internal drink syndrome, or phlegm-heat congestion of the lungs syndrome, or phlegm turbidity obstruction of the lungs syndrome;
- •Voluntarily accept the treatment and sign the informed consent form;
排除标准
- •Pregnant and lactating women.
- •delirious, dementia, various mental patients and other people who cannot communicate normally.
- •Patients with severe cardiac insufficiency (NYHA grade IV), malignant arrhythmia and hemodynamic instability.
- •Patients with acute respiratory failure who require tracheal intubation or invasive mechanical ventilation.
- •Complicated with bronchiectasis, active tuberculosis, severe liver and kidney disease (severe liver disease refers to cirrhosis, portal hypertension and varicose vein bleeding, etc., serious kidney disease including dialysis, kidney transplantation, etc.), pneumonia, HIV infection or immunosuppressive state, advanced malignant tumor, etc.
- •long-term bedridden patients for various reasons.
- •Out-of-hospital treatment for more than 3 days.
- •Participate in other drug clinical investigators within 1 month before enrollment.
- •Allergic to therapeutic drugs.
研究组 & 干预措施
Chinese medicine granules plus western medicine treatment
On the basis of conventional western medicine treatment, the experimental group will be given Sanhan Huayin granule , Qingre Huatan granule or Zaoshi Huatan granule based on CM syndrome differentiation.Take 1 dose daily for 10 days.
干预措施: Sanhan Huayin recipe, Qingre Huatan recipe or Zaoshi Huatan recipe (Drug)
Chinese medicine granules placebo plus western medicine treatment
On the basis of conventional treatment of western medicine, in the experimental group 5% of the placebo drug, color, smell, taste, appearance, weight, similar to the experimental drug, drug packaging and test group. One dose was given daily for 10 days.
干预措施: Sanhan Huayin recipe placebo, Qingre Huatan recipe placebo or Zaoshi Huatan recipe placebo (Drug)
结局指标
主要结局
Treatment failure rate
时间窗: During the 10 days treatment period and the 3 months follow-up period.
The number of treatment failures in both groups during the study period was measured. Treatment failure was defined as the following: (1) the need for or receipt of tracheal intubation or invasive mechanical ventilation during hospitalization, or (2) the need for or transfer to an intensive care unit during hospitalization, or (3) the duration of hospitalization for the current acute exacerbation of COPD for more than 14 days, or (4) death during hospitalization or within 30 days after discharge, or (5) readmission for an acute exacerbation of COPD within 30 days after discharge.
次要结局
- The number and severity of acute exacerbations(Within 3 months of follow-up period.)
- Readmission rate of acute exacerbations(Within 3 months of follow-up period.)
- Antibacterial application time(During the 10 days treatment period and the 3 months follow-up period.)
- Case fatality rate(During the 10 days treatment period and the 3 months follow-up period.)
- The COPD Assessment Test(CAT)(Changes in baseline CAT scores at day 10 of the treatment period and at 1 and 3 months of follow-up.)
- The time to the first exacerbation of COPD(Within 3 months of follow-up period.)
- COPD Acute exacerbation tool (EXACT) score(0 and 10 days in the treatment period, 1 and 3 months in the follow-up period.)
- Dyspnea score(Changes in baseline mMRC scores at days 4, 7, and 10 of the treatment period and at 1 and 3 months of follow-up.)
- Length of hospital stay(During the 10 days treatment period and the 3 months follow-up period.)
- Endotracheal intubation rate(In 10 days of the treatment period.)