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.

Study Overview

• Status: Not yet recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Xiao-Xian-Gui-Fu-Tang

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: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fang-Pey Chen, MD; Phone Number: 886-2-28757453; Email: fpchen@vghtpe.gov.tw

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Taipei Veterans General Hospital
    • Contact: Fang-Pey Chen, MD; Phone Number: 886-2-28757453; Email: fpchen@vghtpe.gov.tw
  • Taipei, Taiwan, 11217
    • Center for Traditional Medicine, Taipei VGH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 28 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 6 years old to 30 years old.
• Diagnosis as an atopic dermatitis patient.
• The score of the SCORAD is over 20. (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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.
Placebo Comparator: 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	week 0, 3, 6, 8, 11, 14
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.	week 0, 3, 6, 8, 11, 14
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.	week 0, 3, 6, 8, 11, 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood test (AST)	blood test at baseline, week 6, and follow-up (14 weeks)	week 0, 6, 14
Blood test (ALT)	blood test at baseline, week 6, and follow-up (14 weeks)	week 0, 6, 14
Blood test (Serum Creatinine)	blood test at baseline, week 6, and follow-up (14 weeks)	week 0, 6, 14
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).	week 0, 6, 14

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan
• Investigators: Principal Investigator: Fang-Pey Chen, MD, Center for Traditional Medicine, Taipei Veterans General Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2021
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: December 16, 2020
• First Submitted That Met QC Criteria: December 27, 2020
• First Posted (Actual): December 29, 2020

Study Record Updates

• Last Update Posted (Actual): December 29, 2020
• Last Update Submitted That Met QC Criteria: December 27, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Integrative medicine; Chinese herbal medicine; Atopic Dermatits
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID 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