Experienced Chinese Herbal Formulas on Pediatric Asthma

Fudan University

Status: Completed

Conditions: Childhood Asthma

Treatments: Drug: experienced chinese herbal formulas; Drug: leukotriene receptor antagonist and bronchial relaxant

Study type: Interventional

Funder types: Other

Identifiers

NCT02341573

No. 12401905500

Details and patient eligibility

About

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.

Full 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.

Enrollment: 182 patients

Sex: All

Ages: 3 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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182 participants in 2 patient groups

chinese medicine group

Experimental group

Description:

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.

Treatment:

Drug: experienced chinese herbal formulas

western medicine group

Active Comparator group

Description:

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.

Treatment:

Drug: leukotriene receptor antagonist and bronchial relaxant