NCT02937207

Study on the Treatment of Bronchial Asthma With Traditional Chinese Medicine

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 288 (estimated)
• Sponsor: Shanghai University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Bronchial Asthma

Interventions

Type	Name	Description
DRUG	Ke Chuan Liu Wei Mixture	Experience formula of famous traditional Chinese professor Yingen Wu
DRUG	Chuan Xiong Ping Chuan Mixture	Experience formula of famous traditional Chinese professor Changrong Shao
DRUG	Xie Wu Capsule	Experience formula of famous traditional Chinese professor Jianhua Hu
DRUG	Dan Ma Jia Tablet	Experience formula of famous traditional Chinese professor Xiaopu Xu
DRUG	Zhi Chuan Capsule	Experience formula of famous traditional Chinese professor Yingen Wu
DRUG	Bu Shen Na Qi Granule	Experience formula of famous traditional Chinese professor Changrong Shao
DRUG	Ke Chuan Liu Wei Mixture placebo	Low dose combination for treating prescription of Ke Chuan Liu Wei Mixture
DRUG	Chuan Xiong Ping Chuan Mixture placebo	Low dose combination for treating prescription of Chuan Xiong Ping Chuan Mixture
DRUG	Xie Wu Capsule placebo	Low dose combination for treating prescription of Xie Wu Capsule
DRUG	Dan Ma Jia Tablet placebo	Low dose combination for treating prescription of Dan Ma Jia Tablet
DRUG	Zhi Chuan Capsule placebo	Low dose combination for treating prescription of Zhi Chuan Capsule
DRUG	Bu Shen Na Qi Granule placebo	Low dose combination for treating prescription of Bu Shen Na Qi Granule

Timeline

• Start date: 2017-07-30
• Primary completion: 2020-12-01
• Completion: 2021-12-01
• First posted: 2016-10-18
• Last updated: 2020-02-26

Locations

5 sites across 1 country: China