The Efficacy of Patients With Moderate to Severe Atopic Dermatitis Treated With Chinese Herbal Medicine

NCT04686955 | Completed Phase 3 DMC

• 1 other identifier: 2019-02-017A
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

Brief Summary

Conduct a clinical trial of integration of Chinese and Western medicine to evaluate whether the association of traditional Chinese medicine therapy has a remission effect on atopic dermatitis, and to explore the remission of lesions after an association of Chinese herbal medicine, and the correlation of syndrome differentiation types before and after treatment with Chinese and Western medicine, with a view to better understand the efficacy of atopic dermatitis in the treatment of the same disease in Traditional Chinese Medicine, and provide another option for patients with atopic dermatitis.

Conditions

Atopic Dermatitis

Keywords

Atopic Dermatits; Chinese herbal medicine; Integrative medicine

Outcome Measures

Primary Outcomes (3)

• Changes of SCORing Atopic Dermatitis(SCORAD) Index

  SCORAD is a clinical tool used to assess the extent and severity of eczema (SCORing Atopic Dermatitis). Dermatologists may use this tool before and after treatment to determine whether the treatment has been effective.

  week 0, 3, 6, 8, 11, 14

• Changes of Dermatology Life Quality Index(DLQI)

  The DLQI is designed to measure the health-related quality of life of adult patients suffering from a skin disease.

  week 0, 3, 6, 8, 11, 14

• Changes of Children's Dermatology Life Quality Index(CDLQI)

  The Children's Dermatology Life Quality Index (CDLQI) is designed to measure the impact of any skin disease on the lives of children.

  week 0, 3, 6, 8, 11, 14

Secondary Outcomes (4)

• Blood test (AST)

  week 0, 6, 14

• Blood test (ALT)

  week 0, 6, 14

• Blood test (Serum Creatinine)

  week 0, 6, 14

• Changes of Constitution in Chinese Medicine Questionnaire

  week 0, 6, 14

Study Arms (2)

Group A

EXPERIMENTAL

Group A will receive Xiao-Xian-Gui-Fu-Tang(VGH4) for 6 weeks, then entry 2 weeks wash-out period. Then switch to receive the placebo for another 6 weeks.

Drug: Xiao-Xian-Gui-Fu-Tang; Drug: Placebo

Group B

PLACEBO COMPARATOR

Group B will receive placebo for 6 weeks, then entry 2 weeks wash-out period. Then switch to receive the Xiao-Xian-Gui-Fu-Tang (VGH4)for another 6 weeks.

Drug: Xiao-Xian-Gui-Fu-Tang; Drug: Placebo

Interventions

Xiao-Xian-Gui-Fu-Tang DRUG

The Xiao-Xian-Gui-Fu-Tang (VGH4) includes Xiao-Feng-San 2.0g, Dang-Gui-Yin-Zi 1.2g, Bai-Xian-Pi (Cortex Dictamni Radicis) 0.4g, and Di-Fu-Zi (Fructus Kochiae) 0.5g. The Xiao-Xian-Gui-Fu-Tang (VGH4) will be manufactured, packaged, and labeled by the KO DA Pharmaceutical Company (Taoyuan, Taiwan), under good manufacturing practice (GMP) standards.

Group A; Group B

Placebo DRUG

Matching placebo composed of inert excipients with similar color, taste, and odor, administered orally daily.

Group A; Group B

Eligibility Criteria

• Age: 6 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years old to 30 years old.
• Diagnosis as an atopic dermatitis patient.
• The score of the SCORAD is over 25. (moderate to severe atopic dermatitis)

You may not qualify if:

• Secondary bacterial infections
• Received oral or intravenous steroid treatment, anti-biotics, phototherapy, or other immunosuppressive therapies in the previous 2 months.
• Received Chinese herbal medicine treatment or acupuncture.
• Pregnant woman or current breastfeeding.
• Who had catastrophes illness now or in the past must be avoided.
• Can not sign informed consent or can not communicate with the researcher.
• Abnormal liver enzymes.
• Abnormal kidney function tests (1.5 times higher than the upper normal limit)

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (2)

Center for Traditional Medicine, Taipei VGH

Taipei, 11217, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

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

• Fang-Pey Chen, MD

  Center for Traditional Medicine, Taipei Veterans General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: December 29, 2020
• Study Start: January 25, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: November 24, 2025

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)