Clinical trial NCT02341573: Experienced Chinese Herbal Formulas on Pediatric Asthma
Official title: Effect of Experienced Chinese Herbal Formulas Based on Different Stages and Different Symptoms on Pediatric Asthma: a Single-blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Asthma
Keywords: Traditional Chinese Medicine
Randomized Controlled Trial
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2015-01-19
Enrollment: 182
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Asthma Control Test Score
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Change in mRNA expression levels of inflammatory mediators
timeFrame: Baseline and 3 months
measure: Change in some index of pulmonary function (PEF,FEV1,VT,etc.) .
timeFrame: Baseline and 3 months
measure: Change in chinese medicine symptoms scores
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Chinese Traditional Medicine; Children Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Children Hospital of Fudan University
name: Wang Y hong, professor
role: STUDY_CHAIR
References: