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

NCT ID: NCT04419584

Last Updated: 2022-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-10
• Study Completion Date: 2023-05-31

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.

Conditions

Atopic Dermatitis

Study Design

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

Study Groups

Modified Qing-Ying Decoction

Herbal granules, twice per day for 12 weeks

Group Type: EXPERIMENTAL

Modified Qing-Ying Decoction

Intervention Type: DRUG

Herbal granules

Identical looking placebo

Placebo granules, twice per day for 12 weeks

Group Type: PLACEBO_COMPARATOR

Identical looking placebo

Intervention Type: DRUG

Placebo granules

Interventions

Modified Qing-Ying Decoction

Herbal granules

Intervention Type: DRUG

Identical looking placebo

Placebo granules

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age of 4 to 17 (Chinese only);

2. With EASI ≥ 10;

3. Subacute and chronic atopic dermatitis presenting with dry, scaly, erythematous papules and plaques; and

4. Provide written informed consent form (signed by one of their parents)

Exclusion Criteria

1. History of allergy to Chinese medicines;

2. 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

3. Known overt bacterial infections in the skin;

4. Known pregnancy;

5. Known severe medical conditions, such as cardiovascular, liver or renal dysfunction or Diabetes Mellitus;

6. Having used oral corticosteroids, oral antibiotics, other immunosuppressive or any preparation of oral herbal medicines for the treatment of AD in the past month;

7. Having been diagnosed with scabies, allergic contact dermatitis, seborrheic dermatitis or psoriasis; and

8. Has taken anti-coagulant or anti-platelet drugs in the past month.

9. Has taken any probiotics, prebiotics in the last month

10. 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

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhi-xiu Lin, PhD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

AD study

Identifier Type: -

Identifier Source: org_study_id