Evaluate the Efficacy of Using Modified Qing-Ying Decoction in Atopic Dermatitis Children
Recruiting · NCT04419584 · Interventional (participants receive a specific treatment) · Lead sponsor: Chinese University of Hong Kong
View the official record on ClinicalTrials.gov →Interventions studied
Identical looking placeboModified Qing-Ying Decoction
What this trial is about
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.
Who can take part
Age range
4 Years to 17 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2, Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- The Chinese University of Hong Kong - Hong Kong, Hong Kong