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

The Chinese University of Hong Kong

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Atopic Dermatitis

Treatments: Drug: Placebo; Drug: Modified Huang-Lian-Jie-Du Decoction (MHLJDD)

Study type: Interventional

Funder types: Other

Identifiers

NCT05613062

AD HLJDD study

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 4 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

Active treatment (Modified Huang-Lian-Jie-Du Decoction (MHLJDD))

Experimental group

Description:

Chinese medicine

Treatment:

Drug: Modified Huang-Lian-Jie-Du Decoction (MHLJDD)

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo