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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hanxiao treatment group | Experimental | 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. |
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| Hanxiao control group | Placebo Comparator | 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. |
|
| Fengtanxiao treatment group | Experimental | 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. |
|
| Fengtanxiao control group | Placebo Comparator | 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. |
|
| Rexiao treatment group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ke Chuan Liu Wei Mixture | Drug | Experience formula of famous traditional Chinese professor Yingen Wu |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zifeng Ma, Master | Contact | +8602164385700 | 1307 | mzf05@126.com |
| Shaoyan Zhang, Doctor | Contact | +8602164385700 | 1307 | 475205883@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhenhui Lu, Doctor | Longhua Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fenglin Street Community Health Service Center | Not yet recruiting | Shanghai | Shanghai Municipality | 200030 | China |
Through this study, to find the appropriate treatment of traditional Chinese medicine, then to further promote
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| Experimental |
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. |
|
| Rexiao control group | Placebo Comparator | 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. |
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| Xuxiao treatment group | Experimental | 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. |
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| Xuxiao control group | Placebo Comparator | 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. |
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| Chuan Xiong Ping Chuan Mixture | Drug | Experience formula of famous traditional Chinese professor Changrong Shao |
|
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| Xie Wu Capsule | Drug | Experience formula of famous traditional Chinese professor Jianhua Hu |
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| Dan Ma Jia Tablet | Drug | Experience formula of famous traditional Chinese professor Xiaopu Xu |
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| Zhi Chuan Capsule | Drug | Experience formula of famous traditional Chinese professor Yingen Wu |
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| Bu Shen Na Qi Granule | Drug | Experience formula of famous traditional Chinese professor Changrong Shao |
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| Ke Chuan Liu Wei Mixture placebo | Drug | Low dose combination for treating prescription of Ke Chuan Liu Wei Mixture |
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| Chuan Xiong Ping Chuan Mixture placebo | Drug | Low dose combination for treating prescription of Chuan Xiong Ping Chuan Mixture |
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| Xie Wu Capsule placebo | Drug | Low dose combination for treating prescription of Xie Wu Capsule |
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| Dan Ma Jia Tablet placebo | Drug | Low dose combination for treating prescription of Dan Ma Jia Tablet |
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| Zhi Chuan Capsule placebo | Drug | Low dose combination for treating prescription of Zhi Chuan Capsule |
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| Bu Shen Na Qi Granule placebo | Drug | Low dose combination for treating prescription of Bu Shen Na Qi Granule |
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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 |
| Kangjian Street Community Health Service Center | Not yet recruiting | Shanghai | Shanghai Municipality | 200030 | China |
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| Tianping Street Community Health Service Center | Not yet recruiting | Shanghai | Shanghai Municipality | 200030 | China |
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| Longhua Hospital Affiliated Shanghai University of TCM | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| Fengxian District Hospital of TCM | Not yet recruiting | Shanghai | Shanghai Municipality | 201400 | China |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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