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

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04419584
• Other study ID #: AD study
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: September 10, 2020
• Est. completion date: May 2023

Study information

• Verified date: June 2022
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 64
• Est. completion date: May 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Modified Qing-Ying Decoction
Herbal granules
• Identical looking placebo
Placebo granules

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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