Modified Qing-Ying Decoction for Atopic Dermatitis in Children
Official title: 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
Run by Chinese University of Hong Kong · NCT04419584 · Data updated 2026-11-12
This study tests whether the modified Qing-Ying Decoction can help improve symptoms and quality of life for children with subacute to chronic atopic dermatitis, compared with a placebo.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 4 Years to 17 Years |
| Sex | All |
| Enrollment | 64 (estimated) |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Status | Recruiting |
| Started | September 10, 2020 |
| Main results expected | June 2027 |
| Study ends | August 2027 |
| Registry record updated | July 30, 2026 |
| Trial ID | NCT04419584 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 4–17 with EASI ≥ 10 and subacute or chronic atopic dermatitis, whose guardians consent to participation.
✕Probably not a fit
Patients with known allergies to Chinese medicines, certain comorbidities, or recent systemic treatments may not benefit or be excluded from the study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, double-blind, placebo-controlled trial in children aged 4 to 17 with atopic dermatitis. Participants receive either oral modified Qing-Ying Decoction granules or an identical placebo for 12 weeks, with a 4-week follow-up. Assessments include EASI, CDLQI, POEM, and Chinese Medicine body constitution at multiple visits, plus gut microbiome analysis and safety monitoring. The study also collects dietary logs and tracks medication compliance and adverse events. The trial aims to understand clinical efficacy, safety, and potential links to gut microbiota and traditional Chinese medicine concepts.
Why it matters
Potential benefit: If successful, the treatment could reduce eczema severity and improve quality of life for children with atopic dermatitis.
How similar studies have gone: Previous studies of herbal formulations in atopic dermatitis have shown mixed efficacy; this trial tests a modified decoction in a rigorous, blinded design.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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The Chinese University of Hong Kong
Hong Kong, Hong Kong Recruiting
Study contacts
- Principal investigator: Zhi-xiu Lin, PhD — Chinese University of Hong Kong
- Study coordinator: Chi-him Sum
- Email: chsum@cuhk.edu.hk
- Phone: 39433438
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.