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

NCT04419584

RecruitingPhase 2, Phase 3

Sponsor: Chinese University of Hong Kong

Conditions: Atopic Dermatitis

Interventions: Modified Qing-Ying Decoction, Identical looking placebo

Countries: Hong Kong

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.

Eligibility overview

Sex: ALL

Age: 4 Years to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Age of 4 to 17 (Chinese only);
2. With EASI ≥ 10;
3. Subacute and chronic atopic dermatitis presenting with dry, scaly, erythematous papules and plaques; and
4. Provide written informed consent form (signed by one of their parents)

Exclusion Criteria:

1. History of allergy to Chinese medicines;
2. 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
3. Known overt bacterial infections in the skin;
4. Known pregnancy;
5. Known severe medical conditions, such as cardiovascular, liver or renal dysfunction or Diabetes Mellitus;
6. Having used oral corticosteroids, oral antibiotics, other immunosuppressive or any preparation of oral herbal medicines for the treatment of AD in the past month;
7. Having been diagnosed with scabies, allergic contact dermatitis, seborrheic dermatitis or psoriasis; and
8. Has taken anti-coagulant or anti-platelet drugs in the past month.
9. Has taken any probiotics, prebiotics in the last month
10. Known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency

Locations (1)

Hong Kong, Hong Kong