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Atopic DermatitisPhase 3NCT04686955

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

A Phase 3 study testing Xiao-Xian-Gui-Fu-Tang in people with Atopic Dermatitis, run by Taipei Veterans General Hospital, Taiwan at 2 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 6 to 30 years
Conditions the study is for
Atopic Dermatitis
What is being tested?
Xiao-Xian-Gui-Fu-Tang
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
19 participants
Where
2 sitesTaiwan
Study dates
25 Jan 2021to 31 Dec 2022
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 30 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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)

Who cannot join

  • 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)

Trial locations and contacts

2 sites in 1 country.

Taiwan2 sites

  • Center for Traditional Medicine, Taipei VGH

    Taipei, 11217

  • Taipei Veterans General Hospital

    Taipei

Other trials in Taiwan

About this study

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.

Read the 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.

Being tested
Xiao-Xian-Gui-Fu-Tang, Placebo
Keywords
Atopic Dermatits, Chinese herbal medicine, Integrative medicine
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Xiao-Xian-Gui-Fu-TangDrug

    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.

  • PlaceboDrug

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

Study groups in NCT04686955
Study groupRoleWhat they receive
Group AExperimentalGroup 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.
Receives: Drug: Xiao-Xian-Gui-Fu-Tang; Drug: Placebo
Group BPlacebo comparatorGroup 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.
Receives: Drug: Xiao-Xian-Gui-Fu-Tang; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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.

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

Secondary outcomes (4)

  1. Blood test (AST)

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

    Measured: week 0, 6, 14

  2. Blood test (ALT)

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

    Measured: week 0, 6, 14

  3. Blood test (Serum Creatinine)

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

    Measured: week 0, 6, 14

  4. Changes of Constitution in Chinese Medicine Questionnaire

    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).

    Measured: week 0, 6, 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2020
  2. Study start25 Jan 2021
  3. Primary completion31 Dec 2022
  4. Study completion31 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04686955
Sponsor's protocol ID
2019-02-017A
Status last verified
Jan 2021
First submitted
16 Dec 2020
Last updated
24 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Xiao-Xian-Gui-Fu-Tang in people with Atopic Dermatitis, run by Taipei Veterans General Hospital, Taiwan at 2 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes of SCORing Atopic Dermatitis(SCORAD) Index (time frame: week 0, 3, 6, 8, 11, 14). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04686955.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.

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