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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Modified Qing-Ying Decoction; Drug: Identical looking placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • The Chinese University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Modified Qing-Ying Decoction; Herbal granules, twice per day for 12 weeks	Drug: Modified Qing-Ying Decoction; Herbal granules
Placebo Comparator: Identical looking placebo; Placebo granules, twice per day for 12 weeks	Drug: Identical looking placebo; Placebo granules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eczema Area and Severity Index (EASI)	Min value: 0, max value: 72, higher scores mean worse outcome. To assess the severity of atopic dermatitis	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Oriented Eczema Measure (POEM)	Min value: 0, max value: 28, higher scores mean worse outcome. To assess the subjective symptoms of subjects.	16 weeks
Children's Dermatology Life Quality Index (CDLQI)	Min value: 0, max value: 30, higher scores mean worse outcome. To assess the quality of life of subjects.	16 weeks
Constitution of Chinese Medicine Questionnaire (CCMQ)	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.	16 weeks

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Zhi-xiu Lin, PhD, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2020
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: June 4, 2020
• First Submitted That Met QC Criteria: June 4, 2020
• First Posted (Actual): June 5, 2020

Study Record Updates

• Last Update Posted (Actual): June 22, 2022
• Last Update Submitted That Met QC Criteria: June 21, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: AD study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No