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Chinese Herbal Medicine Formula Combined With Inhaled Corticosteroids for the Treatment of Mild to Persistent Asthma in Children

NCT05066841 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2021-10-04

No results posted yet for this study

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.

Conditions

  • Childhood Asthma

Interventions

DRUG

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

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

DRUG

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

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

Sponsors & Collaborators

  • China Medical University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-25
Primary Completion
2023-08-31
Completion
2023-09-30

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05066841 on ClinicalTrials.gov