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NCT Number: NCT04686955

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

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

6 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Center for Traditional Medicine, Taipei VGH, Taipei, Taiwan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Placebo

Drug

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

Primary outcomes

  1. Changes of SCORing Atopic Dermatitis(SCORAD) Index

    Time frame: week 0, 3, 6, 8, 11, 14

    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.

  2. Changes of Dermatology Life Quality Index(DLQI)

    Time frame: week 0, 3, 6, 8, 11, 14

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

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

    Time frame: week 0, 3, 6, 8, 11, 14

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

Secondary outcomes

  1. Blood test (AST)

    Time frame: week 0, 6, 14

    blood test at baseline, week 6, and follow-up (14 weeks)

  2. Blood test (ALT)

    Time frame: week 0, 6, 14

    blood test at baseline, week 6, and follow-up (14 weeks)

  3. Blood test (Serum Creatinine)

    Time frame: week 0, 6, 14

    blood test at baseline, week 6, and follow-up (14 weeks)

  4. Changes of Constitution in Chinese Medicine Questionnaire

    Time frame: week 0, 6, 14

    The Constitution in Chinese Medicine Questionnaire (CCMQ) consists of 60 items to classify a person into one or more of nine Body constitution(BC) types: gentleness (8 Items), Qi-deficiency (8 Items), Yang-deficiency (7 Items), Yin-deficiency (8 Items), phlegm-wetness (8 Items), wetness-heat (6 Items), blood-stasis (7 Items), Qi-depression (7 Items), and special diathesis (7 Items). Coexistence of multiple imbalanced BC types was possible which is consistent with the TCM theories. The scoring algorithm proposed in the original CCMQ was adopted in this study. A higher score in the CCMQ BC scale indicates a higher likelihood of the specific BC type, and a score of 30 is set as threshold for case definition. The CCMQ will be conducted at baseline, 12 weeks, and follow-up (16 weeks).

Sponsors and collaborators

Lead sponsor

Taipei Veterans General Hospital, Taiwan

Other Gov

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 29, 2020
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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