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

Primary Purpose

Atopic Dermatitis

Status

Active

Phase

Phase 2

Locations

Hong Kong

Study Type

Interventional

Intervention

Modified Qing-Ying Decoction

Identical looking placebo

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

4 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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 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; 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

Sites / Locations

The Chinese University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Modified Qing-Ying Decoction

Identical looking placebo

Arm Description

Herbal granules, twice per day for 12 weeks

Placebo granules, twice per day for 12 weeks

Outcomes

Primary Outcome Measures

Eczema Area and Severity Index (EASI)

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

Secondary Outcome Measures

Patient Oriented Eczema Measure (POEM)

Min value: 0, max value: 28, higher scores mean worse outcome. To assess the subjective symptoms of subjects.

Children's Dermatology Life Quality Index (CDLQI)

Min value: 0, max value: 30, higher scores mean worse outcome. To assess the quality of life of subjects.

Constitution of Chinese Medicine Questionnaire (CCMQ)

Not a scale. Based on the answers, a logarithm will be used to determine the type of Chinese Medicine Constitution of the subjects. To assess the Chinese medicine body constitution of subjects.

Full Information

NCT ID

NCT04419584

First Posted

June 4, 2020

Last Updated

June 21, 2022

Sponsor

Chinese University of Hong Kong

1. Study Identification

Unique Protocol Identification Number

NCT04419584

Brief Title

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

Official Title

A Randomized Placebo-Controlled Clinical Trial of an Innovative Herbal Formula for Atopic Dermatitis in Children: Evaluations of Modified Qing-Ying Decoction on Efficacy and Gut Microbiome

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

September 10, 2020 (Actual)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

Detailed Description

The subjects will come for a screening visit at week 0 (baseline), then at week 6, week 12, and week 16 for Chinese medicine practitioner (CMP) investigators assessments. Eczema Area and Severity Index (EASI), Children's Dermatology Life Quality Index (CDLQI), Patient-Oriented Eczema Measure (POEM), and Chinese Medicine body constitution types will be assessed and filled up at different timepoints. They will receive oral herbal mQYD or placebo granules for 12 weeks and then be followed up 4 weeks after the treatment. Registered CMPs will provide consultation under Chinese medicine theory. Study medication compliance and adverse events will also be assessed at each visit. Besides, they need to record the food taken in a diary before the day for taking faecal specimen for gut microbiome analysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atopic Dermatitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Modified Qing-Ying Decoction

Arm Type

Experimental

Arm Description

Herbal granules, twice per day for 12 weeks

Arm Title

Identical looking placebo

Arm Type

Placebo Comparator

Arm Description

Placebo granules, twice per day for 12 weeks

Intervention Type

Drug

Intervention Name(s)

Modified Qing-Ying Decoction

Intervention Description

Herbal granules

Intervention Type

Drug

Intervention Name(s)

Identical looking placebo

Intervention Description

Placebo granules

Primary Outcome Measure Information:

Title

Eczema Area and Severity Index (EASI)

Description

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

Time Frame

16 weeks

Secondary Outcome Measure Information:

Title

Patient Oriented Eczema Measure (POEM)

Description

Min value: 0, max value: 28, higher scores mean worse outcome. To assess the subjective symptoms of subjects.

Time Frame

16 weeks

Title

Children's Dermatology Life Quality Index (CDLQI)

Description

Min value: 0, max value: 30, higher scores mean worse outcome. To assess the quality of life of subjects.

Time Frame

16 weeks

Title

Constitution of Chinese Medicine Questionnaire (CCMQ)

Description

Not a scale. Based on the answers, a logarithm will be used to determine the type of Chinese Medicine Constitution of the subjects. To assess the Chinese medicine body constitution of subjects.

Time Frame

16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

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 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; 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhi-xiu Lin, PhD

Organizational Affiliation

Chinese University of Hong Kong

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Chinese University of Hong Kong

City

Hong Kong

Country

Hong Kong

12. IPD Sharing Statement

Plan to Share IPD

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

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