Clinical trial NCT02937207: Study on the Treatment of Bronchial Asthma With Traditional Chinese Medicine
Official title: Study on the Treatment of Bronchial Asthma With Traditional Chinese Medicine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Bronchial Asthma
Keywords: Bronchial Asthma
Traditional Chinese Medicine
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2016-10-18
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Asthma control rate
timeFrame: up to 12 months
Secondary outcomes:
measure: Lung function(FEV1, PVC, PEF)
timeFrame: up to 12 months
measure: Measurement of the fractional concentration of exhaled nitric oxide
timeFrame: up to 12 months
measure: Blood routine examination
timeFrame: up to 12 months
measure: Cytokine levels of serum and induced sputum
timeFrame: up to 12 months
measure: Liver function test
timeFrame: up to 12 months
measure: Kidney function test
timeFrame: up to 12 months
measure: T cell classification
timeFrame: up to 12 months
measure: Cytokine levels of induced sputum
timeFrame: up to 12 months
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: Longhua Hospital
name: Zhenhui Lu, Doctor
role: STUDY_CHAIR
References: