Study on the Treatment of Bronchial Asthma With Traditional Chinese Medicine
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 288
- 试验地点
- 5
- 主要终点
- Asthma control rate
研究概览
简要总结
The purpose of this study is to evaluate the clinical efficacy of traditional Chinese medicine in the treatment of asthma, and to promote the application in community hospitals.
详细描述
Asthma is a serious global health problem and has increasing prevalence in many countries.Although asthma symptoms can be controlled by drug treatment to a large extent, there is still inadequate.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 promote the application in community hospitals. This could constitute a significant advance in asthma management.
In this study, the investigators recruited patients with asthma exacerbation and remission stage, and gave the corresponding western medicine background treatment and traditional Chinese medicine treatment program.Participants will undergo a physical examination, lung function, blood and sputum collection.
Exacerbation group belongs to cold type of asthma patients will take Ke Chuan Liu Wei Mixture, wind phlegm type of asthma patients will take Chuan Xiong Ping Chuan Mixture and Xie Wu Capsule，and hot type of asthma patients will take Dan Ma Jia Tablet for 14 days treatment, while the 3 control groups were given 3 corresponding placebo treatment for a total of 14 days.
Remission phase of Yang deficiency patients in treatment group will take Zhi Chuan Capsule and Bu Shen Na Qi Granule, and in control group received a placebo treatment for a total of 60 days.
Study visits will occur for 7 days of exacerbation group and 1 year for remission group. Questionnaires to assess asthma control will be completed during study of asthma at exacerbation stage within 44 days and on remission period within 12 months.
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)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients had positive bronchodilator reversibility test or positive bronchial challenge test or more than 50 parts per billion of FENO before
- •Number of months without control between 1 and 3 months last year
- •The course of asthma was more than 10 years and less than 30 years
- •Conform to the predetermined 4 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.
- •Long term inhaled corticosteroids (more than 5 years) prior to study entry
- •Pulmonary emphysema, chronic obstructive pulmonary disease, pulmonary emphysema, pulmonary heart disease, pneumonia, lung cancer and other lung diseases
- •Rheumatic immune disease, diabetes, hyperthyroidism, menopause, gastroesophageal reflux, arrhythmia and other complications of the disease
- •Heart, liver, kidney and other organ dysfunction
- •Accompanied by other diseases of long-term use of glucocorticoids, anti allergy drugs, mental or neurological drugs or traditional Chinese Medicine
- •Patients who are allergic to therapeutic medicine
- •Female patients in lactation period, pregnancy or planning to get pregnant during the trial
- •Patients with mental or neurological disorders
研究组 & 干预措施
Hanxiao treatment group
36 patients of exacerbation group belongs to cold type of asthma will take Ke Chuan Liu Wei Mixture oral therapy twice everyday for 14 days and background therapy of ICS and beta2-agonist.
干预措施: Ke Chuan Liu Wei Mixture (Drug)
Hanxiao control group
36 patients of exacerbation group belongs to cold type of asthma will take Ke Chuan Liu Wei Mixture placebo oral therapy twice everyday for 14 days and background therapy of ICS and beta2-agonist.
干预措施: Ke Chuan Liu Wei Mixture placebo (Drug)
Fengtanxiao treatment group
36 patients of exacerbation group belongs to wind phlegm type of asthma will take Chuan Xiong Ping Chuan Mixture and Xie Wu Capsule oral therapy twice everyday for 14 days and background therapy of ICS and beta2-agonist.
干预措施: Chuan Xiong Ping Chuan Mixture (Drug)
Fengtanxiao treatment group
36 patients of exacerbation group belongs to wind phlegm type of asthma will take Chuan Xiong Ping Chuan Mixture and Xie Wu Capsule oral therapy twice everyday for 14 days and background therapy of ICS and beta2-agonist.
干预措施: Xie Wu Capsule (Drug)
Fengtanxiao control group
36 patients of exacerbation group belongs to wind phlegm type of asthma will take Chuan Xiong Ping Chuan Mixture placebo and Xie Wu Capsule placebo oral therapy twice everyday for 14 days and background therapy of ICS and beta2-agonist.
干预措施: Chuan Xiong Ping Chuan Mixture placebo (Drug)
Fengtanxiao control group
36 patients of exacerbation group belongs to wind phlegm type of asthma will take Chuan Xiong Ping Chuan Mixture placebo and Xie Wu Capsule placebo oral therapy twice everyday for 14 days and background therapy of ICS and beta2-agonist.
干预措施: Xie Wu Capsule placebo (Drug)
Rexiao treatment group
36 patients of exacerbation group belongs to hot type of asthma will take Dan Ma Jia Tablet oral therapy thrice everyday for 14 days and background therapy of ICS and beta2-agonist.
干预措施: Dan Ma Jia Tablet (Drug)
Rexiao control group
36 patients of exacerbation group belongs to hot type of asthma will take Dan Ma Jia Tablet placebo oral therapy thrice everyday for 14 days and background therapy of ICS and beta2-agonist.
干预措施: Dan Ma Jia Tablet placebo (Drug)
Xuxiao treatment group
36 patients of remission phase of Yang deficiency of asthma will take Zhi Chuan Capsule and Bu Shen Na Qi Granule oral therapy thrice everyday for 14 days and background therapy of ICS and beta2-agonist.
干预措施: Zhi Chuan Capsule (Drug)
Xuxiao control group
36 patients of remission phase of Yang deficiency of asthma will take Zhi Chuan Capsule placebo and Bu Shen Na Qi Granule placebo oral therapy thrice everyday for 14 days and background therapy of ICS and beta2-agonist.
干预措施: Bu Shen Na Qi Granule placebo (Drug)
Xuxiao treatment group
36 patients of remission phase of Yang deficiency of asthma will take Zhi Chuan Capsule and Bu Shen Na Qi Granule oral therapy thrice everyday for 14 days and background therapy of ICS and beta2-agonist.
干预措施: Bu Shen Na Qi Granule (Drug)
Xuxiao control group
36 patients of remission phase of Yang deficiency of asthma will take Zhi Chuan Capsule placebo and Bu Shen Na Qi Granule placebo oral therapy thrice everyday for 14 days and background therapy of ICS and beta2-agonist.
干预措施: Zhi Chuan Capsule placebo (Drug)
结局指标
主要结局
Asthma control rate
时间窗: up to 12 months
Asthma control rate will be measured during study of asthma at exacerbation stage within 44 days and symptom-free months will be measured on remission period within 12 months
次要结局
- Cytokine levels of serum and induced sputum(up to 12 months)
- Liver function test(up to 12 months)
- Blood routine examination(up to 12 months)
- Kidney function test(up to 12 months)
- T cell classification(up to 12 months)
- Cytokine levels of induced sputum(up to 12 months)
- Lung function(FEV1, PVC, PEF)(up to 12 months)
- Measurement of the fractional concentration of exhaled nitric oxide(up to 12 months)