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NCT Number: NCT04419584

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

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.

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Key information

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

The Chinese University of Hong Kong

Hong Kong

Location status: Recruiting

Location contact

Zhi-xiu Lin, PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Modified Qing-Ying Decoction

Drug

Herbal granules

Identical looking placebo

Drug

Placebo granules

Primary outcomes

  1. Eczema Area and Severity Index (EASI)

    Time frame: 16 weeks

    Min value: 0, max value: 72, higher scores mean worse outcome. To assess the severity of atopic dermatitis

Secondary outcomes

  1. Patient Oriented Eczema Measure (POEM)

    Time frame: 16 weeks

    Min value: 0, max value: 28, higher scores mean worse outcome. To assess the subjective symptoms of subjects.

  2. Children's Dermatology Life Quality Index (CDLQI)

    Time frame: 16 weeks

    Min value: 0, max value: 30, higher scores mean worse outcome. To assess the quality of life of subjects.

  3. Constitution of Chinese Medicine Questionnaire (CCMQ)

    Time frame: 16 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chi-him Sum

CONTACT

[email protected]

39433438

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Jun 5, 2020
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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