Clinical Study on Treatment of Chronic Persistent Bronchial Asthma

Study Overview
=================
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.

Official Title
-----------------
Clinical Study on Treatment of Chronic Persistent Bronchial Asthma With Integrated Traditional Chinese and Western Medicine

Conditions
-----------------
Bronchial Asthma

Intervention / Treatment
-----------------
* Drug: Ke Chuan Liu Wei Granule
* Drug: Yang He Ping Chuan Granule
* Other: Ke Chuan Liu Wei Granule placebo
* Other: Yang He Ping Chuan Granule placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hanxiao treatment group<br>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. | Drug: Ke Chuan Liu Wei Granule<br>* Traditional Chinese Medicine<br>* Other names: KCLW Granule;|
| Sham Comparator: Hanxiao control group<br>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. | Other: Ke Chuan Liu Wei Granule placebo<br>* Placebo<br>* Other names: Placebo;|
| Experimental: Xuxiao treatment group<br>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. | Drug: Yang He Ping Chuan Granule<br>* Traditional Chinese Medicine<br>* Other names: YHPC Granule;|
| Sham Comparator: Xuxiao control group<br>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. | Other: Yang He Ping Chuan Granule placebo<br>* Placebo<br>* Other names: Placebo;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma control rate change | Measured the change from Baseline of asthma control rate | up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung function(FEV1, PEF) | Measured routine pulmonary ventilation function test | Up to 4 weeks | 
| FeNO | The fractional concentration of exhaled nitric oxide | Up to 4 weeks | 
| Blood routine examination | Hematological routine examination | Up to 4 weeks | 
| Liver function test | Simple liver function test | Up to 4 weeks | 
| Cytokine levels of induced sputum | Measured cytokine levels of induced sputum supernatant | Up to 4 weeks | 
| Kidney function test | Simple kidney function test | Up to 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
treatment； bronchial asthma