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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| chinese medicine group | Experimental | Children of chinese medicine group will be treated with experienced chinese herbal formula based on different stages and different symptoms.Patients at the acute stage of asthma will be given Shegan mixture ,at the remission stage, will be treated with Huangqi Bushen mixture-based formulation with modification according to their symptoms,10-30 mL , 2 times a day, for 3 months. |
|
| western medicine group | Active Comparator | Children of western medicine group will be treated with leukotriene receptor antagonist and a bronchial relaxant.Children at the acute stage of asthma will be treated with etinoline,twice a day for 7 days.At the remission stage, they will be given leukotriene receptor antagonist Singulair, once daily for 3 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| experienced chinese herbal formulas | Drug | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Asthma Control Test Score | We will measure the change in asthma control test scores between chinese medicine group and western medicine group. | Baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mRNA expression levels of inflammatory mediators | We will measure the change in mRNA expression levels of some inflammatory mediators in peripheral with Real-time PCR. | Baseline and 3 months |
| Change in some index of pulmonary function (PEF,FEV1,VT,etc.) . |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wang Y hong, professor | Children Hospital of Fudan University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Chinese Traditional Medicine; Children Hospital of Fudan University | Shanghai | Shanghai Municipality | 201102 | China |
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| ID | Term |
|---|---|
| D020024 | Leukotriene Antagonists |
| C093875 | montelukast |
| ID | Term |
|---|---|
| D006727 | Hormone Antagonists |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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| leukotriene receptor antagonist and bronchial relaxant | Drug | At the acute stage of asthma : etinoline,twice a day for 7 days; At the remission stage: Singulair, once daily for 3 months. |
|
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We will measure the change of some index of pulmonary function (PEF,FEV1,VT,etc.) . |
| Baseline and 3 months |
| Change in chinese medicine symptoms scores | 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. | Baseline and 3 months |
| D020164 | Chemical Actions and Uses |