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

NCT ID: NCT04686955

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-25
• Study Completion Date: 2022-12-31

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.

Detailed Description

This examination will be posted at Taipei Veterans General Hospital to recruit 24 participants who meet the inclusion criteria of atopic dermatitis to do the study. After participants agreeing to the clinical study and signing the consent form, the investigators are going to separate them into the A group (12 participants) and the B group (12 participants). The tests are going to take a total of 14 weeks.

Participants need to pass the international diagnostic criteria Hannifin and Rajka to be determined as patients with atopic dermatitis. After, participants need test by scoring Atopic Dermatitis Index (SCORAD) to be determined as mild to moderate atopic dermatitis and accept the Wang Qi Traditional Chinese Medical Constitutional Scale (TCMCS), dermatological quality of life index (DLQI) score or children's skin disease quality of life index (CDLQI) score, routine blood tests, liver and kidney function tests, immunological markers associated with atopic dermatitis Diagnosis of (eosinophils count, ECP, and IgE), tongue diagnosis, and pulse diagnosis. After the collection of data is completed, the investigators will be analyzing the data by SPSS version 21 as a two-paired t-test, ANOVA statistical method, and P <0.05 as a significant result.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group A

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.

Group Type: EXPERIMENTAL

Xiao-Xian-Gui-Fu-Tang

Intervention Type: 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.

Placebo

Intervention Type: DRUG

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

Group B

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.

Group Type: PLACEBO_COMPARATOR

Xiao-Xian-Gui-Fu-Tang

Intervention Type: 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.

Placebo

Intervention Type: DRUG

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

Interventions

Xiao-Xian-Gui-Fu-Tang

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.

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 6 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)

Exclusion Criteria

• 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)

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fang-Pey Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Center for Traditional Medicine, Taipei Veterans General Hospital

Locations

Center for Traditional Medicine, Taipei VGH

Taipei, , Taiwan

Taipei Veterans General Hospital

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

2019-02-017A

Identifier Type: -

Identifier Source: org_study_id