None listed
Conditions
Interventions
treatment group:Pitong Powder Formula
Control group:10% Pitong Powder Formula + 90% Dextrin
Sponsors
Xiyuan Hospital, China Academy of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: (1) Age 18 = age = 60, no gender restrictions; (2) Meets diagnostic criteria outlined in the Chinese Guidelines for the Diagnosis and Treatment of Atopic Dermatitis (2020 Edition). Primary symptom criterion: Skin itching. Secondary symptom criteria: 1) History of involvement in flexural areas, including elbow creases, popliteal fossae, anterior ankles, and neck; 2) History of bronchial asthma or allergic rhinitis; 3) History of generalized skin dryness; 4) Flexural eczema; 5) Onset before age 2. Diagnosis requires primary symptom criteria plus 3 or more secondary criteria. (3) Meets Traditional Chinese Medicine (TCM) pattern identification criteria for Blood Deficiency with Wind-Dryness Syndrome. Primary manifestations: 1) Skin itching with visible scratch marks and scabs; 2) Skin showing lichenification. Secondary symptoms: 1) Dry, rough skin; 2) Darkened skin or hyperpigmentation; 3) Dry mouth and throat; 4) Pale nails; 5) Tongue and pulse: Pale tongue with white coating, thin and wiry pulse. Diagnosis requires all primary symptoms and at least 2 secondary symptoms. (4) AD severity score (SCORAD score) (0–50 points); (5) Subjects have signed informed consent.
Exclusion criteria
Exclusion criteria: (1) Patients with significant cardiovascular, respiratory, gastrointestinal, hepatic, renal, hematologic, neurological, or psychiatric disorders that are unstable or poorly controlled; (2) Patients with any systemic disease or active skin condition that may affect trial outcome assessment, or those with scars, birthmarks, tattoos, or other markings on the affected area that could interfere with evaluation of skin lesions; (3) Patients with malignant tumors; (4) Individuals scheduled for major surgery during the study period; (5) Subjects with severe concomitant conditions requiring systemic hormonal therapy or other interventions that may interfere with study participation or necessitate frequent active monitoring (e.g., unstable chronic asthma); (6) Patients with psychiatric disorders or other conditions likely to interfere with trial participation; (7) Known allergy to any component of the study drug; (8) Pregnant, lactating, or planning pregnancy (excluded by uniform HCG testing); (9) Alcoholics, drug abusers, or individuals with known drug dependency; (10) Use of the following treatments within the specified timeframe prior to enrollment: 1) Second- or third-generation antihistamines (e.g., loratadine, cetirizine, fexofenadine, desloratadine, levocetirizine) within 2 weeks; 2) Systemic immunotherapy within 4 weeks (e.g., glucocorticoids, methotrexate, JAK inhibitors, cyclosporine, etc.); 3) Biologic agents for atopic dermatitis within 4 weeks (or 5 half-lives, whichever is longer) (e.g., IL-4 inhibitors, IL-13 inhibitors, etc.); 4) Ultraviolet therapy or photochemotherapy within 4 weeks; (11) Participation in other drug or medical device clinical trials within 4 weeks; (12) Other subjects deemed ineligible for this clinical study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SCORAD scale ; | — |
Secondary
| Measure | Time frame |
|---|---|
| DLQI score;PP-NRS score;POEM score;ADCT;Traditional Chinese Medicine Syndrome Scoring; | — |
Countries
China
Contacts
Public ContactYanli Song
Xiyuan Hospital, China Academy of Traditional Chinese Medicine
Outcome results
None listed