Effect of Experienced Chinese Herbal Formulas Based on Different Stages and Different Symptoms on Pediatric Asthma: a Single-blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- Change in Asthma Control Test Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patients were excluded if they had congenital respiratory system diseases, tumors, immunodeficiency diseases, or cardiovascular diseases.
研究组 & 干预措施
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.
干预措施: experienced chinese herbal formulas (Drug)
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.
干预措施: leukotriene receptor antagonist and bronchial relaxant (Drug)
结局指标
主要结局
Change in Asthma Control Test Score
时间窗: Baseline and 3 months
We will measure the change in asthma control test scores between chinese medicine group and western medicine group.
次要结局
- Change in mRNA expression levels of inflammatory mediators(Baseline and 3 months)
- Change in some index of pulmonary function (PEF,FEV1,VT,etc.) .(Baseline and 3 months)
- Change in chinese medicine symptoms scores(Baseline and 3 months)
研究者
Yonghong Wang
Professor
Children's Hospital of Fudan University