NCT05613062

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

A Randomized Placebo-Controlled Pilot Study of an Herbal Formula Modified Huang-Lian-Jie-Du Decoction (MHLJDD) for Atopic Dermatitis in Children

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 4 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Modified Huang-Lian-Jie-Du Decoction (MHLJDD)	Chinese medicine granules for 12 weeks twice daily
DRUG	Placebo	Placebo granules for 12 weeks twice daily

Timeline

• Start date: 2023-04-11
• Primary completion: 2023-12-01
• Completion: 2024-06-01
• First posted: 2022-11-14
• Last updated: 2023-07-07

Locations

1 site across 1 country: Hong Kong