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

Last updated: November 18, 2025
Sponsor: Taipei Veterans General Hospital, Taiwan
Overall Status: Completed

Phase

3

Condition

Rash

Allergy

Atopic Dermatitis

Treatment

Xiao-Xian-Gui-Fu-Tang

Placebo

Clinical Study ID

NCT04686955
2019-02-017A
  • Ages 6-30
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Secondary bacterial infections

  • Received oral or intravenous steroid treatment, anti-biotics, phototherapy, or otherimmunosuppressive 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)

Study Design

Total Participants: 19
Treatment Group(s): 2
Primary Treatment: Xiao-Xian-Gui-Fu-Tang
Phase: 3
Study Start date:
January 25, 2021
Estimated Completion Date:
December 31, 2022

Study 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.

Connect with a study center

  • Center for Traditional Medicine, Taipei VGH

    Taipei, 11217
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei,
    Taiwan

    Site Not Available

  • Center for Traditional Medicine, Taipei VGH

    Taipei 1668341, 11217
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei 1668341,
    Taiwan

    Site Not Available

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