Research on Traditional Chinese Medicine (TCM) Clinical Treatment of the Acute Episode of Bronchial Asthma.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 360
- 主要终点
- primary Symptom
研究概览
简要总结
Bronchial asthma is a common disease and frequently encountered disease of respiratory apparatus. It has very complex mechanism and multiple inducing factors. This study will focus on a new Chinese therapy on Bronchial asthma, analyzing the treatment mechanism of internal and external use, based on Traditional Chinese Medicine (TCM) theory and clinical practice. The study will also investigate the efficacy of the Chinese drugs and treatments on Bronchial asthma, and provide an effective therapy for this disease.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 to 65 years old;
- •Patients with mild-to-moderate bronchial asthma on attacking stage;
- •Without cardiopulmonary or other complications;
- •To comply with the diagnostic standard of bronchial asthma in western medicine and TCM syndrome differentiation;
- •Informed consent form is required to be signed.
排除标准
- •Older than 65 years or younger than 18 years old;
- •Pregnant woman or suckling period woman;
- •Patients combine serious primary disease in liver, renal, cardiovascular and cerebrovascular, hemopoietic system diseases,or psychosis.
- •Severe levels of disease is between severe and critical extent. Combine Pulmonary Heart Disease or respiratory failure;
- •Irritable the physique, or allergic to the given composition of drugs in this research;
- •Patients who are in the process of other clinical research.
研究组 & 干预措施
cold type
To comply with the diagnostic standard of bronchial asthma in western medicine and TCM syndrome in cold type
干预措施: warming lung and relieving asthmatic granule and Securing origin and warming lung emplastrum (Other)
heat type
To comply with the diagnostic standard of bronchial asthma in western medicine and TCM syndrome in heat type.
干预措施: clearing lung and relieving asthmatic granule and securing origin and clearing lung emplastrum (Other)
Asthenia type
To comply with the diagnostic standard of bronchial asthma in western medicine and TCM syndrome in Asthenia type.
干预措施: securing origin and relieving asthmatic granule and securing origin and nourishing lung emplastrum (Other)
Western medicine control group
干预措施: Theophylline Sustained-release Tablets and budesonide suspension (Drug)
结局指标
主要结局
primary Symptom
时间窗: 30 days
Symptom: wheezing, cough, choking
physical sign
时间窗: 30 days
physical sign: wheezing sound
assistant examination
时间窗: 30 days
Pulmonary function: mend matters of FEV1, PEF, FEV1/FVC
次要结局
- Secondary Symptom(30 days)
- physical sign(30 days)