Clinical trial NCT04686955: The Efficacy of Patients With Moderate to Severe Atopic Dermatitis Treated With Chinese Herbal Medicine
Official title: The Efficacy of Patients With Moderate to Severe Atopic Dermatitis Treated With Chinese Herbal Medicine
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatits
Chinese herbal medicine
Integrative medicine
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2020-12-29
Enrollment: 24
Sex: ALL
Minimum age (years): 6
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Changes of SCORing Atopic Dermatitis(SCORAD) Index
timeFrame: week 0, 3, 6, 8, 11, 14
measure: Changes of Dermatology Life Quality Index(DLQI)
timeFrame: week 0, 3, 6, 8, 11, 14
measure: Changes of Children's Dermatology Life Quality Index(CDLQI)
timeFrame: week 0, 3, 6, 8, 11, 14
Secondary outcomes:
measure: Blood test (AST)
timeFrame: week 0, 6, 14
measure: Blood test (ALT)
timeFrame: week 0, 6, 14
measure: Blood test (Serum Creatinine)
timeFrame: week 0, 6, 14
measure: Changes of Constitution in Chinese Medicine Questionnaire
timeFrame: week 0, 6, 14
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Center for Traditional Medicine, Taipei VGH
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Center for Traditional Medicine, Taipei Veterans General Hospital
name: Fang-Pey Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: