Experienced Chinese Herbal Formulas on Pediatric Asthma

Not Applicable

Completed

• Conditions: Childhood Asthma
• Interventions: Drug: experienced chinese herbal formulas; Drug: leukotriene receptor antagonist and bronchial relaxant

• Registration Number: NCT02341573
• Lead Sponsor: Children's Hospital of Fudan University

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.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2014-12-31
• Study First Submitted QC: 2015-01-16
• Study First Posted: 2015-01-19
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-10
• Last Update Posted: 2015-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
chinese medicine group	experienced chinese herbal formulas	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	leukotriene receptor antagonist and bronchial relaxant	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Chinese Traditional Medicine; Children Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China