Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease With Qingkepingchuan Granules Clinical Observation of Phlegm-Heat and Lung Depletion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Chinese Medicine Symptoms Scale
研究概览
简要总结
Through the clinical observation of Qingcheng Pingxian Granules in the treatment of acute exacerbation of chronic obstructive pulmonary disease (phlegm-heat lung syndrome), (1) to evaluate the safety of Qingcheng Pingxian Granules in the acute exacerbation of chronic obstructive pulmonary disease; (2) to observe the clinical efficacy of Qingcheng Pingxian Granules in the treatment of acute exacerbation of chronic obstructive pulmonary disease, to provide an effective medication and solution for the treatment of acute exacerbation of chronic obstructive pulmonary disease, and to provide data for the development of the further application of Qingcheng Pingxian Granules.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnostic criteria of AECOPD.
- •Chinese medicine diagnosis is consistent with phlegm-heat and lung depletion evidence
- •40 years old ≤ age ≤ 90 years old
- •Patients who signed the informed consent form and volunteered to participate in the study
排除标准
- •Combined with other primary lung diseases such as bronchial asthma, bronchiectasis, etc.
- •Combination of serious cardiovascular, urinary, digestive, haematopoietic, endocrine metabolic system diseases, other psychiatric and neurological diseases.
- •Pregnant or lactating patients.
- •Allergic to the clinical trial drugs.
研究组 & 干预措施
treatment group
Qingkepingchuan Granules+Conventional basic therapy
干预措施: Qingkepingchuan Granules (Drug)
control subjects
Conventional basic therapy
干预措施: conventional treatment (Other)
结局指标
主要结局
Chinese Medicine Symptoms Scale
时间窗: Before the start of treatment, 1 week of treatment, 2 weeks of treatment, 1 month of follow-up
Record changes in patients' TCM indicators。The scale includes cough, wheezing, shortness of breath, sputum volume, chest tightness, sputum colour, sputum quality, fever, thirst, irritability, constipation, tongue coating, and pulse. The first four items are rated 0-6, and the last nine items are rated 0-3, with higher ratings indicating poorer treatment outcomes.
COPD assessment test
时间窗: Before the start of treatment, 1 week of treatment, 2 weeks of treatment, 1 month of follow-up
Record changes in the patient's condition
breathlessness measurement using the modified British Medical Research Council
时间窗: Before the start of treatment, 1 week of treatment, 2 weeks of treatment, 1 month of follow-up
Record changes in the patient's condition
次要结局
- 6-minute walking test(Before the start of treatment, 2 weeks of treatment)
研究者
Zhang Zhijie
PhD
Beijing University of Chinese Medicine