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Experienced Chinese Herbal Formulas on Pediatric Asthma

Primary Purpose

Childhood Asthma

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
experienced chinese herbal formulas
leukotriene receptor antagonist and bronchial relaxant
Sponsored by
Children's Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Childhood Asthma focused on measuring Traditional Chinese Medicine, Randomized Controlled Trial

Eligibility Criteria

3 Years - 12 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • Department of Chinese Traditional Medicine; Children Hospital of Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

chinese medicine group

western medicine group

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change in Asthma Control Test Score
We will measure the change in asthma control test scores between chinese medicine group and western medicine group.

Secondary Outcome Measures

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.
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.) .
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.

Full Information

First Posted
December 31, 2014
Last Updated
August 10, 2015
Sponsor
Children's Hospital of Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT02341573
Brief Title
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

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital of Fudan University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Asthma
Keywords
Traditional Chinese Medicine, Randomized Controlled Trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
182 (Actual)

8. Arms, Groups, and Interventions

Arm Title
chinese medicine group
Arm Type
Experimental
Arm 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.
Arm Title
western medicine group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
experienced chinese herbal formulas
Other Intervention Name(s)
Shegan mixture ,Huangqi Bushen mixture
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
leukotriene receptor antagonist and bronchial relaxant
Other Intervention Name(s)
Singulair,etinoline,
Intervention Description
At the acute stage of asthma : etinoline,twice a day for 7 days; At the remission stage: Singulair, once daily for 3 months.
Primary Outcome Measure Information:
Title
Change in Asthma Control Test Score
Description
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 Outcome Measure Information:
Title
Change in mRNA expression levels of inflammatory mediators
Description
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
Title
Change in some index of pulmonary function (PEF,FEV1,VT,etc.) .
Description
We will measure the change of some index of pulmonary function (PEF,FEV1,VT,etc.) .
Time Frame
Baseline and 3 months
Title
Change in chinese medicine symptoms scores
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wang Y hong, professor
Organizational Affiliation
Children Hospital of Fudan University
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Chinese Traditional Medicine; Children Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201102
Country
China

12. IPD Sharing Statement

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