Clinical Study on Treatment of Chronic Persistent Bronchial Asthma With Integrated Traditional Chinese and Western Medicine
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 320
- 试验地点
- 5
- 主要终点
- Asthma control rate change
研究概览
简要总结
Investigators aimed to evaluate the clinical efficacy of integrated traditional Chinese and Western medicine in the treatment of asthma, and to further optimize the prescription of Chinese medicine treatment.
详细描述
The incidence of asthma in China is high and the rate of control is low. Traditional Chinese medicine has a long history of treating asthma, and has a good clinical curative effect.The purpose of this study is to evaluate the clinical efficacy of traditional Chinese medicine in the treatment of asthma, and to further optimize the prescription of Chinese medicine treatment.
In this study, investigators recruited chronic persistent asthma participants, and gave the corresponding western medicine background treatment and traditional Chinese medicine treatment program for 28 days.Participants will undergo a physical examination, lung function, blood and sputum collection.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Double-blind trial
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
- •Patient diagnosed with chronic persistent asthma
- •Patients had positive bronchodilator reversibility test or positive bronchial challenge test or more than 50 parts per billion of FENO before
- •Conform to the predetermined 2 TCM Syndrome Types
- •Patients who have given written informed consent
排除标准
- •Smoking and continuous exposure to hazardous environment
- •With fever, or severity of intermittent state, high degree of sustained, or with respiratory failure, etc.
- •Pulmonary emphysema, chronic obstructive pulmonary disease, pulmonary emphysema, pulmonary heart disease, pneumonia, lung cancer and other lung diseases
- •Patients who are allergic to therapeutic medicine
研究组 & 干预措施
Hanxiao treatment group
80 patients belongs to Hanxiao type of asthma will take Ke Chuan Liu Wei Granule oral therapy twice everyday for 28 days and receive background therapy of ICS and beta2-agonist.
干预措施: Ke Chuan Liu Wei Granule (Drug)
Hanxiao control group
80 patients belongs to Hanxiao type of asthma will take Ke Chuan Liu Wei Granule placebo oral therapy twice everyday for 28 days and receive background therapy of ICS and beta2-agonist.
干预措施: Ke Chuan Liu Wei Granule placebo (Other)
Xuxiao treatment group
80 patients of deficiency type of asthma will take Yang He Ping Chuan Granule oral therapy thrice everyday for 28 days and background therapy of ICS and beta2-agonist.
干预措施: Yang He Ping Chuan Granule (Drug)
Xuxiao control group
80 patients of deficiency type of asthma will take Yang He Ping Chuan Granule placebo oral therapy thrice everyday for 28 days and background therapy of ICS and beta2-agonist.
干预措施: Yang He Ping Chuan Granule placebo (Other)
结局指标
主要结局
Asthma control rate change
时间窗: up to 4 weeks
Measured the change from Baseline of asthma control rate
次要结局
- Kidney function test(Up to 4 weeks)
- Lung function(FEV1, PEF)(Up to 4 weeks)
- Liver function test(Up to 4 weeks)
- Cytokine levels of induced sputum(Up to 4 weeks)
- FeNO(Up to 4 weeks)
- Blood routine examination(Up to 4 weeks)