Clinical trial Recruiting at 1 site Phase2; Phase3 Interventional Ages 4 to 17

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

PhasePhase2; Phase3
Study typeInterventional
Ages4 Years to 17 Years
SexAll
Enrollment64 (estimated)
SponsorChinese University of Hong Kong
Academic / other
Locations1 site (Hong Kong)
StatusRecruiting
StartedSeptember 10, 2020
Main results expectedJune 2027
Study endsAugust 2027
Registry record updatedJuly 30, 2026
Trial IDNCT04419584 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

  • 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

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.