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Experienced Chinese Herbal Formulas on Pediatric Asthma

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Children's Hospital of Fudan University

关键词

抽象

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.

描述

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.

日期

最后验证: 07/31/2015
首次提交: 12/30/2014
提交的预估入学人数: 01/15/2015
首次发布: 01/18/2015
上次提交的更新: 08/09/2015
最近更新发布: 08/10/2015
实际学习开始日期: 02/28/2013
预计主要完成日期: 05/31/2015
预计完成日期: 05/31/2015

状况或疾病

Childhood Asthma

干预/治疗

Drug: chinese medicine group

Drug: western medicine group

-

手臂组

干预/治疗
Experimental: chinese medicine group
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.
Drug: chinese medicine group
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.
Active Comparator: western medicine group
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.
Drug: western medicine group
At the acute stage of asthma : etinoline,twice a day for 7 days; At the remission stage: Singulair, once daily for 3 months.

资格标准

有资格学习的年龄 3 Years 至 3 Years
有资格学习的性别All
接受健康志愿者
标准

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.

结果

主要结果指标

1. 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.

次要成果指标

1. 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.

2. 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.) .

3. 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.

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