Childhood Asthma
Conditions
Keywords
Traditional Chinese Medicine, Randomized Controlled Trial
Brief summary
The purpose of this study is conducting a randomized, single blind, controlled intervention trial to observe the therapeutic effect of experienced chinese herbal formulas based on different stages and different symptoms in pediatric asthma.
Detailed description
Pediatric bronchial asthma is a common disease that severely threatens physical and mental health of children. It's urgent to explore effective ways to alleviate the pain caused by asthma. In our research, 160 asthmatic children are randomly divided into a Chinese medication group (80 cases) and a Western medication control group(80 cases). Patients in the Chinese medication group are treated with a series of experienced chinese herbal formulas, whereas the western medication control group received a leukotriene receptor antagonist and a bronchial relaxant. The Chinese medicine syndromes and western medicine symptoms are scored. Pulmonary function and asthma control test score will be applied in this study. We evaluate the situation of asthma from different aspects, including index of pulmonary function and score of asthma control test. Real-time PCR was used to determine the mRNA expression levels of some inflammatory mediators in peripheral.
Interventions
DRUGexperienced chinese herbal formulas
At the acute stage of asthma :Shegan mixture ; At the remission stage:Huangqi Bushen mixture; 10-30 mL , 2 times a day, for 3 months.
DRUGleukotriene receptor antagonist and bronchial relaxant
At the acute stage of asthma : etinoline,twice a day for 7 days; At the remission stage: Singulair, once daily for 3 months.
Sponsors
Children's Hospital of Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Patients were included if they (a) were satisfying the above-mentioned diagnostic criteria with pediatric asthma and cough variation asthma, (b) aged 3-12 years, and (c) were with pattern of phlegm-heat obstruction and cold fluid-retention in lungs at the acute stage, or with pattern of lung-spleen deficiency and kidneyQideficiency at the remission stage of asthma based on traditional chinese medicine syndrome differentiation diagnosis.
Exclusion criteria
* Patients were excluded if they had congenital respiratory system diseases, tumors, immunodeficiency diseases, or cardiovascular diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Asthma Control Test Score | Baseline and 3 months | We will measure the change in asthma control test scores between chinese medicine group and western medicine group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in mRNA expression levels of inflammatory mediators | Baseline and 3 months | We will measure the change in mRNA expression levels of some inflammatory mediators in peripheral with Real-time PCR. |
| Change in some index of pulmonary function (PEF,FEV1,VT,etc.) . | Baseline and 3 months | We will measure the change of some index of pulmonary function (PEF,FEV1,VT,etc.) . |
| Change in chinese medicine symptoms scores | Baseline and 3 months | We will measure the Change in scores of chinese medicine symptoms(cough,expectoration,asthma attacks) according to the Traditional Chinese Medicine Guideline Scale: 0 - 3. 0 = None. 1 = Mild. 2 = Moderate. 3= Severe. |
Countries
China
Outcome results
None listed