NCT02341573

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
182

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 31, 2014

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 19, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

August 11, 2015

Status Verified

August 1, 2015

Enrollment Period

2.3 years

First QC Date

December 31, 2014

Last Update Submit

August 10, 2015

Conditions

Childhood Asthma

Keywords

Traditional Chinese MedicineRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • Change in Asthma Control Test Score

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

    Baseline and 3 months

Secondary Outcomes (3)

  • Change in mRNA expression levels of inflammatory mediators

    Baseline and 3 months

  • Change in some index of pulmonary function (PEF,FEV1,VT,etc.) .

    Baseline and 3 months

  • Change in chinese medicine symptoms scores

    Baseline and 3 months

Study Arms (2)

chinese medicine group

EXPERIMENTAL

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.

Drug: experienced chinese herbal formulas

western medicine group

ACTIVE COMPARATOR

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.

Drug: leukotriene receptor antagonist and bronchial relaxant

Interventions

experienced chinese herbal formulasDRUG

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.

Also known as: Shegan mixture ,Huangqi Bushen mixture
chinese medicine group
leukotriene receptor antagonist and bronchial relaxantDRUG

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

Also known as: Singulair,etinoline,
western medicine group

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients were excluded if they had congenital respiratory system diseases, tumors, immunodeficiency diseases, or cardiovascular diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Chinese Traditional Medicine; Children Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

MeSH Terms

Interventions

Leukotriene Antagonistsmontelukast

Intervention Hierarchy (Ancestors)

Hormone AntagonistsHormones, Hormone Substitutes, and Hormone AntagonistsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Wang Y hong, professor

    Children Hospital of Fudan University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 31, 2014

First Posted

January 19, 2015

Study Start

March 1, 2013

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

August 11, 2015

Record last verified: 2015-08

Locations

CN(1)