NCT05066841

Brief Summary

The purpose of study is to provide an objective data for evaluating the efficacy and safety of Chinese medicine (CM) formula combined with inhaled corticosteroid in the treatment of asthmatic children. Investigators will recruit eighty-six mild to moderate asthmatic children aged 4-11 years old with regular ICS usage and they will be randomized into two groups in this double-blind trial. Forty-three subjects will receive CM (CM group; Ma-Hsing-Kan-Shih-Tang in combination with Liu-Jun-Zi-Tang) and the other forty-three subjects will receive placebo (placebo group; 10% CM) for 12 weeks. Investigators will compare these two groups by questionnaires of Childhood Asthma Control Test (cACT), the Integrated Therapeutics Group Child Asthma Short Form (ITG-CASF), Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ), the pulmonary function test and blood test including Complete Blood Count with Differential Count (CBC/DC), total IgE, Eosinophil Cationic Protein (ECP) and IL-4/IL-5/IL-13. Adverse events, renal and liver function test will be evaluated to investigate the safety of CM formula as well.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2021

Completed
18 days until next milestone

Study Start

First participant enrolled

September 25, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 4, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

October 4, 2021

Status Verified

September 1, 2021

Enrollment Period

1.9 years

First QC Date

September 7, 2021

Last Update Submit

October 1, 2021

Conditions

Childhood Asthma

Keywords

childhood asthmainhaled corticosteroidsChinese medicineMa-Hsing-Kan-Shih-TangLiu-Jun-Zi-Tang

Outcome Measures

Primary Outcomes (1)

  • The change of Childhood Asthma Control Test (cACT)

    cACT questionnaire is a tool to evaluate asthma symptoms

    week 12

Secondary Outcomes (9)

  • The change of FEV1/FVC (%) in spirometry

    week 12

  • The change of CBC/DC

    week 12

  • The change of total IgE

    week 12

  • The change of the ECP

    week 12

  • The change of IL-4

    week 12

  • +4 more secondary outcomes

Other Outcomes (4)

  • The frequency of acute exacerbation

    week 12

  • Adverse drug reaction (ADR) during study period

    week 12

  • The change of the renal function test

    week 12

  • +1 more other outcomes

Study Arms (2)

CM group

EXPERIMENTAL
Drug: CM (Ma-Hsing-Kan-Shih-Tang in combination with Liu-Jun-Zi-Tang)

placebo group

PLACEBO COMPARATOR
Drug: 10% CM (Ma-Hsing-Kan-Shih-Tang in combination with Liu-Jun-Zi-Tang)

Interventions

10% CM (Ma-Hsing-Kan-Shih-Tang in combination with Liu-Jun-Zi-Tang)DRUG

10% CM (Ma-Hsing-Kan-Shih-Tang in combination with Liu-Jun-Zi-Tang) and 90% starch for 12 weeks

placebo group
CM (Ma-Hsing-Kan-Shih-Tang in combination with Liu-Jun-Zi-Tang)DRUG

CM (Ma-Hsing-Kan-Shih-Tang in combination with Liu-Jun-Zi-Tang) for 12 weeks

CM group

Eligibility Criteria

Age4 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • aged 4-11 years old
  • GINA (Global Initiative for Asthma) guideline belong to mild to moderate asthmatic children
  • regular use low dose ICS+ LABA or medium dose ICS at least one month

You may not qualify if:

  • asthma with acute exacerbation or ever has used systemic steroids in recent one month
  • psychiatric disease or behavior disorder
  • ever has received Chinese herbal medicine or other traditional Chinese medicine treatment in recent two weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

China Medical University Hospital

Taichung, 404, Taiwan

RECRUITING

MeSH Terms

Interventions

liu-jun-zi-tang

Central Study Contacts

Chieh Wang

CONTACT

+886963619537u9923035@cmu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

September 7, 2021

First Posted

October 4, 2021

Study Start

September 25, 2021

Primary Completion

August 31, 2023

Study Completion

September 30, 2023

Last Updated

October 4, 2021

Record last verified: 2021-09

Locations

TW(1)