Atopic Dermatitis
Conditions
Interventions
control group:Patients in the control group received one or more medications selected from 0.1% triamcinolone acetonide cream (a topical corticosteroid), 0.1% tacrolimus ointment (a topical calcineuri
treatment group:The treatment group received orally administered Xieling Qushi Granules (150 mL, twice daily) in addition to the conventional therapy provided to the control group.
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Meet the diagnostic criteria for mild to moderate atopic dermatitis; (2) Fulfill the TCM pattern differentiation criteria for the damp-heat stasis pattern; (3) Aged 18 to 80 years, inclusive; (4) No gender restrictions; (5) Voluntary participation, evidenced by providing dated written informed consent after being fully informed of all study-related content, and willingness and ability to comply with all scheduled visits, treatment plans, laboratory tests, and other study procedures.
Exclusion criteria
Exclusion criteria: (1) Atopic dermatitis involving special areas (e.g., perianal, vulvar, scrotal, or breast regions); (2) Participants with other active dermatological conditions (e.g., psoriasis or lupus erythematosus) or active skin infections (bacterial, fungal, or viral) that could interfere with the assessment of atopic dermatitis; or those with severe comorbidities (e.g., unstable chronic asthma) that may require systemic corticosteroid therapy, other interventions, or intensive and frequent monitoring; (3) Presence of severe hepatic or renal dysfunction, cardiovascular and cerebrovascular diseases, hematologic system disorders, psychiatric disorders, etc.; patients with malignant tumors or other severe systemic diseases that may confound the accurate evaluation of treatment efficacy; (4) Use of Chinese medical therapies (e.g., oral/herbal Chinese medicine, acupuncture) which, in the investigator's judgment, could potentially interfere with the evaluation of atopic dermatitis; (5) Individuals with a history of general allergic diathesis (highly allergic constitution) or known/suspected allergy to any herbal component of the investigational formula; (6) Patients currently participating in another clinical trial or using other investigational drugs; (7) Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| scoring atopic dermatitisindex;traditional Chinese medicine Syndrome Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Response Rate;Investigator Global Assessment;Dermatology Life Quality Index;Peak Pruritus Numerical Rating Scale;Frequency and dosage of topical medication;Frequency and dosage of oral Western medication; Immunoglobulin E;eosinophil count;interleukin-6;interleukin-2;interleukin-4;interleukin-5;interleukin-10;interleukin-17;Interferon-?;tumor necrosis factor-a; | — |
Countries
China
Contacts
Public ContactDuan Xiaohong
Huashan Hospital, Fudan University
Outcome results
None listed