Atopic dermatitis
Conditions
Interventions
Experimental Group:Aloxone cream for external use and oral administration of Zishen Jianpi Qingre decoction
Control group:Elozon cream was applied topically
Sponsors
Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
Eligibility
Sex/Gender
All
Age
2 Years to 16 Years
Inclusion criteria
Inclusion criteria: (1) Meet the clinical diagnostic criteria of mild to moderate atopic dermatitis with IGA score > 1; (2) in accordance with the syndrome differentiation standard of spleen deficiency and lung heat syndrome; (3) age between 2 and 16 years old, both sexes; (4) no systemic use of glucocorticoids, immunosuppressants, biological agents or ultraviolet rays within 4 weeks before the study; (5) no oral antihistamines within 3 days before the study; (6) no use of topical corticosteroids or calcineurin inhibitors within 2 weeks before the study; (7) The legal guardians of the subjects could fully understand the purpose of the trial, use drugs according to the instructions of doctors during the whole study period, voluntarily participate in and sign the informed consent.
Exclusion criteria
Exclusion criteria: (1) skin diseases other than AD in the area requiring treatment; (2) children with severe systemic diseases (such as cardiovascular system, respiratory system, digestive system, nervous system, endocrine system, urogenital system, etc.) and immunodeficiency diseases; (3) patients with serious skin infection or systemic infection; (4) patients with a history of allergy to any component of the study drug; (5) patients who could not accept TCM decoction treatment; (6) The child was currently participating in other clinical studies or had participated in other clinical studies within 3 months, and the investigator judged that the child had poor compliance and could not complete the study as required.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease maintenance rate and time to first relapse; | — |
Secondary
| Measure | Time frame |
|---|---|
| POEM for Patients with Eczema;Eczema Area and Severity Index (EASI);Pruritus Peak Numerical Rating Scale (NRS-11);Clinical laboratory tests included basophils, LTC4, NGF, IL-4, IL-13 and IL-31 in peripheral blood;Visual analogue scale (VAS) of sleep loss;Infantile Dermatitis Quality of Life Questionnaire (IDQOL)/Pediatric Dermatology Life Quality Index (CDLQI);Number of topical ointment elosone used; | — |
Countries
China
Contacts
Public ContactXu Jia
Department of Dermatology, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Dongcheng District, Beijing
Outcome results
None listed