atopic dermatitis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Meeting both the Hanifin-Rajka diagnostic criteria for atopic dermatitis and the TCM pattern differentiation points for spleen deficiency with dampness pattern as outlined in the International Clinical Practice Guideline for Traditional Chinese Medicine: Atopic Dermatitis;(2) Aged 6 to 65 years ;regardless of sex;(3) SCORAD score between 25 and 50 points;(4) Voluntarily agree to participate and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Pregnant or lactating patients; patients (male or female) with reproductive planning;(2) Individuals with known hypersensitivity to the investigational drug or its components;(3) Patients with underlying diseases that may interfere with treatment or study outcomes including but not limited to: diabetes mellitus cardiovascular/cerebrovascular disorders severe primary hepatic/renal diseases favism coagulopathies psychiatric disorders malignancies; concurrent infectious diseases (e.g. tuberculosis hepatitis); or immunodeficiency syndromes;(4) Patients with concomitant skin diseases affecting lesion assessment (e.g. scabies psoriasis seborrheic dermatitis);(5) Patients demonstrating poor compliance inability to cooperate with clinical observation or current participation in other drug trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pruritus VAS;SCORAD; | — |
Secondary
| Measure | Time frame |
|---|---|
| EASI;IL-4;IL-13;IGA;POEM;IL-5;IgE;Eosinophil;DLQI/CDLQI;Sleep VAS;SCH;TWEL; | — |
Countries
China
Contacts
No.111 Dade Road Yuexiu District Guangzhou City Guangdong Province China