Experienced Chinese Herbal Formulas on Pediatric Asthma

Children's Hospital of Fudan University182 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

182

Conditions

Childhood Asthma

Interventions

experienced chinese herbal formulasDRUG

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.

leukotriene receptor antagonist and bronchial relaxantDRUG

At the acute stage of asthma : etinoline,twice a day for 7 days; At the remission stage: Singulair, once daily for 3 months.

Eligibility

Sex: ALLMin age: 3 YearsMax age: 12 Years

Medical Language ↔ Plain English

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.

Locations (1)

Department of Chinese Traditional Medicine; Children Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Change in Asthma Control Test Score

We will measure the change in asthma control test scores between chinese medicine group and western medicine group.

Time frame: Baseline and 3 months

Secondary Outcomes

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.

Time frame: Baseline and 3 months

Change in some index of pulmonary function (PEF,FEV1,VT,etc.) .

We will measure the change of some index of pulmonary function (PEF,FEV1,VT,etc.) .

Time frame: 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.

Time frame: Baseline and 3 months

Data from ClinicalTrials.gov

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