Clinical trial NCT03228134: Clinical Study on Treatment of Chronic Persistent Bronchial Asthma
Official title: Clinical Study on Treatment of Chronic Persistent Bronchial Asthma With Integrated Traditional Chinese and Western Medicine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Bronchial Asthma
Keywords: treatment； bronchial asthma
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Longhua Hospital
First posted: 2017-07-24
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All treatment group received traditional chinese medicine plus a standard anti-asthma treatment on study entry, and the control group received placebo and standard anti-asthma treatment.
Primary purpose: TREATMENT

Brief summary: Investigators aimed to evaluate the clinical efficacy of integrated traditional Chinese and Western medicine in the treatment of asthma, and to further optimize the prescription of Chinese medicine treatment.

Detailed description: The incidence of asthma in China is high and the rate of control is low. 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 further optimize the prescription of Chinese medicine treatment.

In this study, investigators recruited chronic persistent asthma participants, and gave the corresponding western medicine background treatment and traditional Chinese medicine treatment program for 28 days.Participants will undergo a physical examination, lung function, blood and sputum collection.

Eligibility criteria: Inclusion Criteria:

* Patient diagnosed with chronic persistent asthma
* Patients had positive bronchodilator reversibility test or positive bronchial challenge test or more than 50 parts per billion of FENO before
* Conform to the predetermined 2 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.
* Pulmonary emphysema, chronic obstructive pulmonary disease, pulmonary emphysema, pulmonary heart disease, pneumonia, lung cancer and other lung diseases
* Patients who are allergic to therapeutic medicine

Primary outcomes:
measure: Asthma control rate change
timeFrame: up to 4 weeks
Secondary outcomes:
measure: Lung function(FEV1, PEF)
timeFrame: Up to 4 weeks
measure: FeNO
timeFrame: Up to 4 weeks
measure: Blood routine examination
timeFrame: Up to 4 weeks
measure: Liver function test
timeFrame: Up to 4 weeks
measure: Cytokine levels of induced sputum
timeFrame: Up to 4 weeks
measure: Kidney function test
timeFrame: Up to 4 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fenglin Street Community Health Service Center
state: Shanghai
city: Shanghai
country: China
facility: Kangjian Street Community Health Service Center
state: Shanghai
city: Shanghai
country: China
facility: Tianping Street Community Health Service Center
state: Shanghai
city: Shanghai
country: China
facility: Longhua Hospital Affiliated Shanghai University of TCM
state: Shanghai
city: Shanghai
country: China
facility: Fengxian District Hospital of TCM
state: Shanghai
Study officials:
affiliation: tcmdoctorzhang@163.com
name: Huiyong Zhang, Director
role: PRINCIPAL_INVESTIGATOR
References: