Clinical Study on Treatment of Chronic Persistent Bronchial Asthma
- Conditions
- Bronchial Asthma
- Interventions
- Other: Ke Chuan Liu Wei Granule placeboOther: Yang He Ping Chuan Granule placebo
- Registration Number
- NCT03228134
- Lead Sponsor
- Shanghai University of Traditional Chinese Medicine
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 320
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hanxiao control group Ke Chuan Liu Wei Granule placebo 80 patients belongs to Hanxiao type of asthma will take Ke Chuan Liu Wei Granule placebo oral therapy twice everyday for 28 days and receive background therapy of ICS and beta2-agonist. Xuxiao treatment group Yang He Ping Chuan Granule 80 patients of deficiency type of asthma will take Yang He Ping Chuan Granule oral therapy thrice everyday for 28 days and background therapy of ICS and beta2-agonist. Xuxiao control group Yang He Ping Chuan Granule placebo 80 patients of deficiency type of asthma will take Yang He Ping Chuan Granule placebo oral therapy thrice everyday for 28 days and background therapy of ICS and beta2-agonist. Hanxiao treatment group Ke Chuan Liu Wei Granule 80 patients belongs to Hanxiao type of asthma will take Ke Chuan Liu Wei Granule oral therapy twice everyday for 28 days and receive background therapy of ICS and beta2-agonist.
- Primary Outcome Measures
Name Time Method Asthma control rate change up to 4 weeks Measured the change from Baseline of asthma control rate
- Secondary Outcome Measures
Name Time Method Lung function(FEV1, PEF) Up to 4 weeks Measured routine pulmonary ventilation function test
Liver function test Up to 4 weeks Simple liver function test
FeNO Up to 4 weeks The fractional concentration of exhaled nitric oxide
Blood routine examination Up to 4 weeks Hematological routine examination
Cytokine levels of induced sputum Up to 4 weeks Measured cytokine levels of induced sputum supernatant
Kidney function test Up to 4 weeks Simple kidney function test
Trial Locations
- Locations (5)
Fenglin Street Community Health Service Center
🇨🇳Shanghai, Shanghai, China
Fengxian District Hospital of TCM
🇨🇳Shanghai, Shanghai, China
Kangjian Street Community Health Service Center
🇨🇳Shanghai, Shanghai, China
Tianping Street Community Health Service Center
🇨🇳Shanghai, Shanghai, China
Longhua Hospital Affiliated Shanghai University of TCM
🇨🇳Shanghai, Shanghai, China