Study on the Treatment of Bronchial Asthma With Traditional Chinese Medicine

Phase 2

• Conditions: Bronchial Asthma
• Interventions: Drug: Ke Chuan Liu Wei Mixture placebo; Drug: Ke Chuan Liu Wei Mixture; Drug: Chuan Xiong Ping Chuan Mixture; Drug: Zhi Chuan Capsule; Drug: Chuan Xiong Ping Chuan Mixture placebo; Drug: Zhi Chuan Capsule placebo; Drug: Dan Ma Jia Tablet; Drug: Dan Ma Jia Tablet placebo; Drug: Xie Wu Capsule placebo; Drug: Bu Shen Na Qi Granule; Drug: Bu Shen Na Qi Granule placebo; Drug: Xie Wu Capsule

• Registration Number: NCT02937207
• Lead Sponsor: Shanghai University of Traditional Chinese Medicine

Brief 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.

Study Timeline

• Study First Submitted: 2016-10-14
• Study First Submitted QC: 2016-10-17
• Study First Posted: 2016-10-18
• Study Start: 2017-07-30
• Status Verified: 2019-12
• Last Update Submitted: 2020-02-24
• Last Update Posted: 2020-02-26
• Primary Completion: 2020-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 288

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hanxiao control group	Ke Chuan Liu Wei Mixture placebo	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.
Hanxiao treatment group	Ke Chuan Liu Wei Mixture	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.
Fengtanxiao treatment group	Chuan Xiong Ping Chuan Mixture	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.
Xuxiao treatment group	Zhi Chuan Capsule	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.
Fengtanxiao control group	Chuan Xiong Ping Chuan Mixture placebo	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.
Xuxiao control group	Zhi Chuan Capsule placebo	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.
Fengtanxiao control group	Xie Wu Capsule placebo	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	Dan Ma Jia Tablet	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	Dan Ma Jia Tablet placebo	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.
Xuxiao treatment group	Bu Shen Na Qi Granule	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.
Xuxiao control group	Bu Shen Na Qi Granule placebo	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.
Fengtanxiao treatment group	Xie Wu Capsule	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.

Primary Outcome Measures

Name	Time	Method
Asthma control rate	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

Secondary Outcome Measures

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

Trial Locations

Locations (5)

Fenglin Street Community Health Service Center; 🇨🇳 Shanghai, Shanghai, China

Kangjian Street Community Health Service Center; 🇨🇳 Shanghai, Shanghai, China

Longhua Hospital Affiliated Shanghai University of TCM; 🇨🇳 Shanghai, Shanghai, China

Tianping Street Community Health Service Center; 🇨🇳 Shanghai, Shanghai, China

Fengxian District Hospital of TCM; 🇨🇳 Shanghai, Shanghai, China