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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04686955
• Other study ID #: 2019-02-017A
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: December 2020
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Fang-Pey Chen, MD
• Phone: 886-2-28757453
• Email: fpchen[@]vghtpe.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 30 Years

Eligibility

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)

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Center for Traditional Medicine, Taipei VGH	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Blood test (AST)	blood test at baseline, week 6, and follow-up (14 weeks)	week 0, 6, 14
Secondary	Blood test (ALT)	blood test at baseline, week 6, and follow-up (14 weeks)	week 0, 6, 14
Secondary	Blood test (Serum Creatinine)	blood test at baseline, week 6, and follow-up (14 weeks)	week 0, 6, 14
Secondary	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