Modified Huang-Lian-Jie-Du Decoction (MHLJDD) for Atopic Dermatitis in Children

Chinese University of Hong Kong20 enrolled

Overview

The study aims to evaluate the clinical efficacy of Chinese medicine (CM) for the treatment of subacute and chronic Atopic Dermatitis (AD) patients when compared to the placebo control by examining the clinical symptoms.

This is a parallel, randomized, placebo-controlled, double-blind pilot study. The subjects will come for a screening visit at week 0 (baseline), then at week 6±3 days, week 12±3 days and week 16±4 days for Chinese medicine practitioner (CMP) investigators' assessments (Fig 1). Eczema Area and Severity Index (EASI), Children's dermatology life quality index (CDLQI), and Patient-Oriented Eczema Measure (POEM) will be assessed and filled up at different time points. Eligible subjects will be randomly allocated to the treatment group receiving oral CM granules or the placebo control group receiving oral placebo granules for 12 weeks, and then be followed up 4 weeks after the treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Atopic Dermatitis

Interventions

Modified Huang-Lian-Jie-Du Decoction (MHLJDD)DRUG

Chinese medicine granules for 12 weeks twice daily

PlaceboDRUG

Placebo granules for 12 weeks twice daily

Eligibility

Sex: ALLMin age: 4 YearsMax age: 17 Years

Medical Language ↔ Plain English

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 a 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; * Has taken anti-coagulant or anti-platelet drugs in the past month; * Has taken any probiotics, prebiotics in the last month; and * Known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Locations (1)

School of Chinese Medicine

Hong Kong, Hong Kong

Outcomes

Primary Outcomes

EASI score

The change of EASI score for atopic dermatitis at week 12 Min value: 0, max value: 72, higher scores mean worse outcome. To assess the severity of atopic dermatitis.

Time frame: 12 weeks

Secondary Outcomes

EASI score

The change of EASI score for atopic dermatitis at week 6 Min value: 0, max value: 72, higher scores mean worse outcome. To assess the severity of atopic dermatitis

Time frame: 6 weeks

EASI score

The change of EASI score for atopic dermatitis at week16 Min value: 0, max value: 72, higher scores mean worse outcome. To assess the severity of atopic dermatitis

Time frame: 16 weeks

CDLQI score

The change of CDLQI score at week 12 Min value: 0, max value: 30, higher scores mean worse outcome. To assess the quality of life of subjects.

Time frame: 12 weeks

CDLQI score

The change of CDLQI score at week 16 Min value: 0, max value: 30, higher scores mean worse outcome. To assess the quality of life of subjects.

Time frame: 16 weeks

POEM score

The change of POEM score at week 12 Min value: 0, max value: 28, higher scores mean worse outcome. To assess the subjective symptoms of subjects.

Time frame: 12 weeks

POEM score

The change of POEM score at week 16 Min value: 0, max value: 28, higher scores mean worse outcome. To assess the subjective symptoms of subjects.

Time frame: 16 weeks

Data from ClinicalTrials.gov

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