Study on the Treatment of Bronchial Asthma With Traditional Chinese Medicine

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Study on the Treatment of Bronchial Asthma With Traditional Chinese Medicine

Conditions
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Bronchial Asthma

Intervention / Treatment
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* Drug: Ke Chuan Liu Wei Mixture
* Drug: Chuan Xiong Ping Chuan Mixture
* Drug: Xie Wu Capsule
* Drug: Dan Ma Jia Tablet
* Drug: Zhi Chuan Capsule
* Drug: Bu Shen Na Qi Granule
* Drug: Ke Chuan Liu Wei Mixture placebo
* Drug: Chuan Xiong Ping Chuan Mixture placebo
* Drug: Xie Wu Capsule placebo
* Drug: Dan Ma Jia Tablet placebo
* Drug: Zhi Chuan Capsule placebo
* Drug: Bu Shen Na Qi Granule placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hanxiao treatment group<br>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. | Drug: Ke Chuan Liu Wei Mixture<br>* Experience formula of famous traditional Chinese professor Yingen Wu<br>* Other names: Ke Chuan Liu Wei He Ji;|
| Placebo Comparator: Hanxiao control group<br>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. | Drug: Ke Chuan Liu Wei Mixture placebo<br>* Low dose combination for treating prescription of Ke Chuan Liu Wei Mixture<br>* Other names: placebo;|
| Experimental: Fengtanxiao treatment group<br>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. | Drug: Chuan Xiong Ping Chuan Mixture<br>* Experience formula of famous traditional Chinese professor Changrong Shao<br>* Other names: Chuan Xiong Ping Chuan He Ji;Drug: Xie Wu Capsule<br>* Experience formula of famous traditional Chinese professor Jianhua Hu<br>* Other names: Xie Wu Jiao Nang;|
| Placebo Comparator: Fengtanxiao control group<br>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. | Drug: Chuan Xiong Ping Chuan Mixture placebo<br>* Low dose combination for treating prescription of Chuan Xiong Ping Chuan Mixture<br>* Other names: placebo;Drug: Xie Wu Capsule placebo<br>* Low dose combination for treating prescription of Xie Wu Capsule<br>* Other names: placebo;|
| Experimental: Rexiao treatment group<br>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. | Drug: Dan Ma Jia Tablet<br>* Experience formula of famous traditional Chinese professor Xiaopu Xu<br>* Other names: Dan Ma Jia Pian;|
| Placebo Comparator: Rexiao control group<br>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. | Drug: Dan Ma Jia Tablet placebo<br>* Low dose combination for treating prescription of Dan Ma Jia Tablet<br>* Other names: placebo;|
| Experimental: Xuxiao treatment group<br>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. | Drug: Zhi Chuan Capsule<br>* Experience formula of famous traditional Chinese professor Yingen Wu<br>* Other names: Zhi Chuan Jiao Nang;Drug: Bu Shen Na Qi Granule<br>* Experience formula of famous traditional Chinese professor Changrong Shao<br>* Other names: Bu Shen Na Qi Ke Li;|
| Placebo Comparator: Xuxiao control group<br>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. | Drug: Zhi Chuan Capsule placebo<br>* Low dose combination for treating prescription of Zhi Chuan Capsule<br>* Other names: placebo;Drug: Bu Shen Na Qi Granule placebo<br>* Low dose combination for treating prescription of Bu Shen Na Qi Granule<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma control rate | 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 | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung function(FEV1, PVC, PEF) | Measured during study of asthma at exacerbation stage within 44 days and on remission period within 12 months | up to 12 months | 
| Measurement of the fractional concentration of exhaled nitric oxide | Measured during study of asthma at exacerbation stage within 44 days and on remission period within 12 months | up to 12 months | 
| Blood routine examination | Measured during study of asthma at exacerbation stage within 44 days and on remission period within 12 months | up to 12 months | 
| Cytokine levels of serum and induced sputum | Measured during study of asthma at exacerbation stage within 44 days and on remission period within 12 months | up to 12 months | 
| Liver function test | Measured Liver function | up to 12 months | 
| Kidney function test | Measured Kidney function | up to 12 months | 
| T cell classification | Measured T cell classification of PBMC | up to 12 months | 
| Cytokine levels of induced sputum | Measured cytokine levels of induced sputum supernatant | up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bronchial Asthma, Traditional Chinese Medicine