Bronchial Asthma
Conditions
Keywords
Bronchial Asthma, 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.
Interventions
DRUGKe Chuan Liu Wei Mixture
Experience formula of famous traditional Chinese professor Yingen Wu
DRUGChuan Xiong Ping Chuan Mixture
Experience formula of famous traditional Chinese professor Changrong Shao
DRUGXie Wu Capsule
Experience formula of famous traditional Chinese professor Jianhua Hu
DRUGDan Ma Jia Tablet
Experience formula of famous traditional Chinese professor Xiaopu Xu
DRUGZhi Chuan Capsule
Experience formula of famous traditional Chinese professor Yingen Wu
DRUGBu Shen Na Qi Granule
Experience formula of famous traditional Chinese professor Changrong Shao
DRUGKe Chuan Liu Wei Mixture placebo
Low dose combination for treating prescription of Ke Chuan Liu Wei Mixture
DRUGChuan Xiong Ping Chuan Mixture placebo
Low dose combination for treating prescription of Chuan Xiong Ping Chuan Mixture
DRUGXie Wu Capsule placebo
Low dose combination for treating prescription of Xie Wu Capsule
DRUGDan Ma Jia Tablet placebo
Low dose combination for treating prescription of Dan Ma Jia Tablet
DRUGZhi Chuan Capsule placebo
Low dose combination for treating prescription of Zhi Chuan Capsule
DRUGBu Shen Na Qi Granule placebo
Low dose combination for treating prescription of Bu Shen Na Qi Granule
Sponsors
Shanghai University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Liver function test | up to 12 months | Measured Liver function |
Countries
China
Contacts
Primary ContactZifeng Ma, Master
Backup ContactShaoyan Zhang, Doctor
Outcome results
None listed