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

November 18, 2025 updated by: Taipei Veterans General Hospital, Taiwan
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 11217
        • Center for Traditional Medicine, Taipei VGH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 26 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Drug: 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.
Drug: Placebo
Matching placebo composed of inert excipients with similar color, taste, and odor, administered orally daily.
Placebo Comparator: 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.
Drug: 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.
Drug: Placebo
Matching placebo composed of inert excipients with similar color, taste, and odor, administered orally daily.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
week 0, 3, 6, 8, 11, 14
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.
week 0, 3, 6, 8, 11, 14
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.
week 0, 3, 6, 8, 11, 14

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Blood test (AST)
Time Frame: week 0, 6, 14
blood test at baseline, week 6, and follow-up (14 weeks)
week 0, 6, 14
Blood test (ALT)
Time Frame: week 0, 6, 14
blood test at baseline, week 6, and follow-up (14 weeks)
week 0, 6, 14
Blood test (Serum Creatinine)
Time Frame: week 0, 6, 14
blood test at baseline, week 6, and follow-up (14 weeks)
week 0, 6, 14
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).
week 0, 6, 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Taipei Veterans General Hospital, Taiwan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Fang-Pey Chen, MD, Center for Traditional Medicine, Taipei Veterans General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 25, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 16, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 27, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 29, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019-02-017A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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