A Phase 2 interventional study of Ke Chuan Liu Wei Mixture and Chuan Xiong Ping Chuan Mixture in Bronchial Asthma, sponsored by Shanghai University of Traditional Chinese Medicine. Status unknown at 5 sites in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-26.
Sponsored by Shanghai University of Traditional Chinese Medicine · Phase 2, Interventional, and Treatment
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.
3,921 studies on the registry are indexed under Asthma; 506 are open to participants now.
This study's planned enrollment of 288 is above the median of 83 across 2,751 interventional studies indexed under Asthma.
Browse Asthma studies →Shanghai University of Traditional Chinese Medicine is the lead sponsor of 99 studies on the registry; 19 are open to participants now.
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Exclusion Criteria:
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
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
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 · Drug: Xie Wu Capsule
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 · Drug: Xie Wu Capsule placebo
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
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
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 · Drug: Bu Shen Na Qi Granule
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 · Drug: Bu Shen Na Qi Granule placebo
Experience formula of famous traditional Chinese professor Yingen Wu
Also known as: Ke Chuan Liu Wei He Ji
Experience formula of famous traditional Chinese professor Changrong Shao
Also known as: Chuan Xiong Ping Chuan He Ji
Experience formula of famous traditional Chinese professor Jianhua Hu
Also known as: Xie Wu Jiao Nang
Experience formula of famous traditional Chinese professor Xiaopu Xu
Also known as: Dan Ma Jia Pian
Experience formula of famous traditional Chinese professor Yingen Wu
Also known as: Zhi Chuan Jiao Nang
Experience formula of famous traditional Chinese professor Changrong Shao
Also known as: Bu Shen Na Qi Ke Li
Low dose combination for treating prescription of Ke Chuan Liu Wei Mixture
Also known as: placebo
Low dose combination for treating prescription of Chuan Xiong Ping Chuan Mixture
Also known as: placebo
Low dose combination for treating prescription of Xie Wu Capsule
Also known as: placebo
Low dose combination for treating prescription of Dan Ma Jia Tablet
Also known as: placebo
Low dose combination for treating prescription of Zhi Chuan Capsule
Also known as: placebo
Low dose combination for treating prescription of Bu Shen Na Qi Granule
Also known as: placebo
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
Time frame: up to 12 months
Lung function(FEV1, PVC, PEF)
Measured during study of asthma at exacerbation stage within 44 days and on remission period within 12 months
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: up to 12 months
Liver function test
Measured Liver function
Time frame: up to 12 months
Kidney function test
Measured Kidney function
Time frame: up to 12 months
T cell classification
Measured T cell classification of PBMC
Time frame: up to 12 months
Cytokine levels of induced sputum
Measured cytokine levels of induced sputum supernatant
Time frame: up to 12 months
Plan to share: Undecided — Through this study, to find the appropriate treatment of traditional Chinese medicine, then to further promote
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This study is status unknown, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Shanghai University of Traditional Chinese Medicine