Evaluate the Efficacy of Using Modified Qing-Ying Decoction in Atopic Dermatitis Children

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Placebo-Controlled Clinical Trial of an Innovative Herbal Formula for Atopic Dermatitis in Children: Evaluations of Modified Qing-Ying Decoction on Efficacy and Gut Microbiome

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: Modified Qing-Ying Decoction
* Drug: Identical looking placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of 4 to 17 (Chinese only); With EASI ≥ 10; Subacute and chronic atopic dermatitis presenting with dry, scaly, erythematous papules and plaques; and Provide written informed consent form (signed by one of their parents) Exclusion Criteria: History of allergy to Chinese medicines; AD with Yang deficiency in syndrome differentiation, such as pale looking, always feeling cold, fatigue, chronic diarrhea with loose stool, urinary disorders such as urinary difficulty, excessive urination or incontinence Known overt bacterial infections in the skin; Known pregnancy; Known severe medical conditions, such as cardiovascular, liver or renal dysfunction or Diabetes Mellitus; Having used oral corticosteroids, oral antibiotics, other immunosuppressive or any preparation of oral herbal medicines for the treatment of AD in the past month; Having been diagnosed with scabies, allergic contact dermatitis, seborrheic dermatitis or psoriasis; and Has taken anti-coagulant or anti-platelet drugs in the past month. Has taken any probiotics, prebiotics in the last month Known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modified Qing-Ying Decoction<br>Herbal granules, twice per day for 12 weeks | Drug: Modified Qing-Ying Decoction<br>* Herbal granules<br>|
| Placebo Comparator: Identical looking placebo<br>Placebo granules, twice per day for 12 weeks | Drug: Identical looking placebo<br>* Placebo granules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |