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NCT Number: NCT02341573

Experienced Chinese Herbal Formulas on Pediatric Asthma

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.

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Key information

Conditions

Childhood Asthma

Age range

3 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Chinese Traditional Medicine; Children Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

experienced chinese herbal formulas

Drug

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.

Other names: Shegan mixture ,Huangqi Bushen mixture

leukotriene receptor antagonist and bronchial relaxant

Drug

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

Other names: Singulair,etinoline,

Primary outcomes

  1. Change in Asthma Control Test Score

    Time frame: Baseline and 3 months

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

Secondary outcomes

  1. Change in mRNA expression levels of inflammatory mediators

    Time frame: 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.) .

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Official study title

Effect of Experienced Chinese Herbal Formulas Based on Different Stages and Different Symptoms on Pediatric Asthma: a Single-blinded Randomized Controlled Trial

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jan 19, 2015
Registry last updated
Aug 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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