The Efficacy of Patients With Moderate to Severe Atopic Dermatitis Treated With Chinese Herbal Medicine
NCT ID: NCT04686955
Last Updated: 2020-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
24 participants
INTERVENTIONAL
2021-01-01
2022-12-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Group A
Group A will receive Xiao-Xian-Gui-Fu-Tang three times per day for 6 weeks, then entry 2 weeks wash-out period. Then switch to receive the placebo for another 6 weeks. Post-follow-up will be 4 weeks later.
Xiao-Xian-Gui-Fu-Tang
The Xiao-Xian-Gui-Fu-Tang 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 will be manufactured, packaged, and labeled by the KO DA Pharmaceutical Company (Taiwan), using good manufacturing practice standards.
Group B
Group B will receive a placebo three times per day for 6 weeks, then entry 2 weeks wash-out period. Then switch to receive the Xiao-Xian-Gui-Fu-Tang for another 6 weeks. Post-follow-up will be 4 weeks later.
Xiao-Xian-Gui-Fu-Tang
The Xiao-Xian-Gui-Fu-Tang 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 will be manufactured, packaged, and labeled by the KO DA Pharmaceutical Company (Taiwan), using good manufacturing practice standards.
Interventions
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Xiao-Xian-Gui-Fu-Tang
The Xiao-Xian-Gui-Fu-Tang 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 will be manufactured, packaged, and labeled by the KO DA Pharmaceutical Company (Taiwan), using good manufacturing practice standards.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis as an atopic dermatitis patient.
* The score of the SCORAD is over 20. (moderate to severe atopic dermatitis)
Exclusion Criteria
* 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)
6 Years
30 Years
ALL
No
Sponsors
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Taipei Veterans General Hospital, Taiwan
OTHER_GOV
Responsible Party
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Principal Investigators
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Fang-Pey Chen, MD
Role: PRINCIPAL_INVESTIGATOR
Center for Traditional Medicine, Taipei Veterans General Hospital
Locations
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Center for Traditional Medicine, Taipei VGH
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Fang-Pey Chen, MD
Role: primary
Fang-Pey Chen, MD
Role: primary
Other Identifiers
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2019-02-017A
Identifier Type: -
Identifier Source: org_study_id