Evaluate the Efficacy of Using Modified Qing-Ying Decoction in Atopic Dermatitis Children

NCT04419584 | Unknown Phase 2

• 1 other identifier: AD study
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to evaluate the clinical efficacy and safety of the modified Qing-Ying Decoction (mQYD) for the treatment of subacute and chronic atopic dermatitis (AD) in children when compared to the placebo control through examining the clinical symptoms, quality of life, gut microbiome, and Chinese medicine body constitution. This is a parallel, randomized, placebo-controlled, double-blind clinical trial. Eligible subjects will be randomly allocated to receive oral mQYD granules or it's placebo granules. Subjects will have 12-week of treatment, and then a 4-week follow-up.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Eczema Area and Severity Index (EASI)

  Min value: 0, max value: 72, higher scores mean worse outcome. To assess the severity of atopic dermatitis

  16 weeks

Secondary Outcomes (3)

• Patient Oriented Eczema Measure (POEM)

  16 weeks

• Children's Dermatology Life Quality Index (CDLQI)

  16 weeks

• Constitution of Chinese Medicine Questionnaire (CCMQ)

  16 weeks

Study Arms (2)

Modified Qing-Ying Decoction

EXPERIMENTAL

Herbal granules, twice per day for 12 weeks

Drug: Modified Qing-Ying Decoction

Identical looking placebo

PLACEBO COMPARATOR

Placebo granules, twice per day for 12 weeks

Drug: Identical looking placebo

Interventions

Modified Qing-Ying Decoction DRUG

Herbal granules

Modified Qing-Ying Decoction

Identical looking placebo DRUG

Placebo granules

Identical looking 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 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; and
• Has taken anti-coagulant or anti-platelet drugs in the past month.
• Has taken any probiotics, prebiotics in the last month
• Known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

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

• Zhi-xiu Lin, PhD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: Associate professor

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 5, 2020
• Study Start: September 10, 2020
• Primary Completion: December 31, 2022
• Study Completion: May 1, 2023
• Last Updated: June 22, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)