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The study aims to evaluate the clinical efficacy and safety of the modified Qing-Ying Decoction (mQYD) for the treatment of subacute and chronic atopic dermatitis (AD) in children when compared to the placebo control through examining the clinical symptoms, quality of life, gut microbiome, and Chinese medicine body constitution.
This is a parallel, randomized, placebo-controlled, double-blind clinical trial. Eligible subjects will be randomly allocated to receive oral mQYD granules or it's placebo granules. Subjects will have 12-week of treatment, and then a 4-week follow-up.
The subjects will come for a screening visit at week 0 (baseline), then at week 6, week 12, and week 16 for Chinese medicine practitioner (CMP) investigators assessments. Eczema Area and Severity Index (EASI), Children's Dermatology Life Quality Index (CDLQI), Patient-Oriented Eczema Measure (POEM), and Chinese Medicine body constitution types will be assessed and filled up at different timepoints. They will receive oral herbal mQYD or placebo granules for 12 weeks and then be followed up 4 weeks after the treatment. Registered CMPs will provide consultation under Chinese medicine theory. Study medication compliance and adverse events will also be assessed at each visit. Besides, they need to record the food taken in a diary before the day for taking faecal specimen for gut microbiome analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modified Qing-Ying Decoction | Experimental | Herbal granules, twice per day for 12 weeks |
|
| Identical looking placebo | Placebo Comparator | Placebo granules, twice per day for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified Qing-Ying Decoction | Drug | Herbal granules |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Eczema Area and Severity Index (EASI) | Min value: 0, max value: 72, higher scores mean worse outcome. To assess the severity of atopic dermatitis | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Oriented Eczema Measure (POEM) | Min value: 0, max value: 28, higher scores mean worse outcome. To assess the subjective symptoms of subjects. | 16 weeks |
| Children's Dermatology Life Quality Index (CDLQI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhi-xiu Lin, PhD | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Chinese University of Hong Kong | Hong Kong | Hong Kong |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| Identical looking placebo |
| Drug |
Placebo granules |
|
Min value: 0, max value: 30, higher scores mean worse outcome. To assess the quality of life of subjects.
| 16 weeks |
| Constitution of Chinese Medicine Questionnaire (CCMQ) | Not a scale. Based on the answers, a logarithm will be used to determine the type of Chinese Medicine Constitution of the subjects. To assess the Chinese medicine body constitution of subjects. | 16 weeks |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |