Using Modified Huang-Lian-Jie-Du Decoction to treat 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
This study is testing if a special Chinese medicine can help children aged 4 to 17 with Atopic Dermatitis feel better over 12 weeks compared to a placebo.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 4 Years to 17 Years |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT05613062 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of Modified Huang-Lian-Jie-Du Decoction (MHLJDD), a form of Chinese medicine, in treating subacute and chronic Atopic Dermatitis (AD) in children aged 4 to 17. The study is designed as a parallel, randomized, placebo-controlled, double-blind pilot trial, where participants will be assessed at multiple time points over a 12-week treatment period. Clinical symptoms will be measured using standardized tools such as the Eczema Area and Severity Index (EASI) and the Children's Dermatology Life Quality Index (CDLQI). Participants will be randomly assigned to receive either the MHLJDD or a placebo, with follow-up assessments conducted four weeks post-treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are Chinese children aged 4 to 17 with moderate to severe Atopic Dermatitis.
Not a fit: Patients with a history of allergy to Chinese medicines or those with specific medical conditions such as severe cardiovascular or renal dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide an effective alternative for managing Atopic Dermatitis in children, potentially improving their quality of life.
How similar studies have performed: While the use of Chinese medicine for Atopic Dermatitis is a novel approach, similar studies have shown promising results in other conditions, suggesting potential efficacy.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Hong Kong
- School of Chinese Medicine — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Zhixiu Lin — Integrative Medical Centre
- Study coordinator: Cho Wing Lo
- Email: louislo@cuhk.edu.hk
- Phone: 35053476
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.