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

NCT05613062 | Unknown Phase 1 DMC

• 1 other identifier: AD HLJDD study
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (16)

• EASI score

  6 weeks

• EASI score

  16 weeks

• CDLQI score

  12 weeks

• CDLQI score

  16 weeks

• POEM score

  12 weeks

Study Arms (2)

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

EXPERIMENTAL

Chinese medicine

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

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

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

Chinese medicine granules for 12 weeks twice daily

Also known as: Chinese medicine

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

Placebo DRUG

Placebo granules for 12 weeks twice daily

Placebo

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

School of Chinese Medicine

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Zhixiu Lin

  Integrative Medical Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cho Wing Lo

CONTACT

35053476; louislo@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: November 14, 2022
• Study Start: April 11, 2023
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: July 7, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)