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

NCT ID: NCT05613062

Last Updated: 2023-07-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-11
• Study Completion Date: 2024-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Chinese medicine

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Chinese medicine granules for 12 weeks twice daily

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo granules for 12 weeks twice daily

Interventions

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

Chinese medicine granules for 12 weeks twice daily

Intervention Type: DRUG

Placebo

Placebo granules for 12 weeks twice daily

Intervention Type: DRUG

Other Intervention Names

Chinese medicine

Eligibility 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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Prof. Lin Zhixiu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhixiu Lin

Role: PRINCIPAL_INVESTIGATOR

Integrative Medical Centre

Locations

School of Chinese Medicine

Hong Kong, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Cho Wing Lo

Role: CONTACT

louislo@cuhk.edu.hk

35053476

Facility Contacts

Zhixiu LIN

Role: primary

28733252

Other Identifiers

AD HLJDD study

Identifier Type: -

Identifier Source: org_study_id