Chinese Herbal Medicine Formula Combined With Inhaled Corticosteroids for the Treatment of Mild to Persistent Asthma in Children
NCT ID: NCT05066841
Last Updated: 2021-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
86 participants
INTERVENTIONAL
2021-09-25
2023-09-30
Brief Summary
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Detailed Description
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This study aims to evaluate the efficacy and safety of Chinese medicine (CM) formula combined with inhaled corticosteroid for the treatment of mild to moderate persistent asthma in children. Investigators focus on the following specific aims: Aim 1. To determine the efficacy of the CM formula (Ma-Hsing-Kan-Shih-Tang in combination with Liu-Jun-Zi-Tang) compared with placebo; Aim 2. To evaluate the effects of CM formula on quality of life in these patients with pediatric asthma; Aim 3. To investigate the safety of CM formula in these patients with pediatric asthma.
Eighty-six mild to moderate asthmatic children aged 4-11 years old with regular ICS usage 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. The evaluation including pulmonary function test, IOS, FeNO, blood test, questionnaire and asthma diary card of both two groups will be conducted during the study period. The safety of CM formula use will be investigated by recording the adverse events and renal and liver function test as well.
This study will provide an objective data for evaluating the efficacy and safety o of Chinese medicine (CM) formula combined with inhaled corticosteroid in the treatment of asthmatic children. Through the combination of Chinese and western medicine, we expect to enhance the efficacy of asthma treatment, reduce acute exacerbation and tapper the dose of inhaled corticosteroids, leading to better quality of life.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CM group
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
placebo group
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* psychiatric disease or behavior disorder
* ever has received Chinese herbal medicine or other traditional Chinese medicine treatment in recent two weeks
4 Years
11 Years
ALL
No
Sponsors
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China Medical University Hospital
OTHER
Responsible Party
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Chieh Wang
Attending physician
Locations
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China Medical University Hospital
Taichung, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CMUH109-REC2-111
Identifier Type: -
Identifier Source: org_study_id
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