Plaque psoriasis
Conditions
Interventions
Experimental Group:Kai Xuan Xiao Yin Decoction
Control Group:Calcipotriol
Sponsors
Shandong University of Traditional Chinese Medicine Affiliated Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: (1) Meets the diagnostic criteria for plaque psoriasis. Specifically: (Western Medical Diagnostic Criteria): Meets the diagnostic criteria for plaque psoriasis as outlined in the "Chinese Guidelines for the Diagnosis and Treatment of Psoriasis (2023 Edition)": Clinical manifestations: Rashes are well-defined erythematous plaques or infiltrated erythema, covered with white or silvery-white scales, with diameters ranging from 1 to several centimeters; physical examination reveals the "Auspitz's sign," "film phenomenon," "point bleeding phenomenon," and "koebner phenomenon"; nail changes may include punctate depressions, "pinhead" appearance, even nail separation, and nail opacity or thickening; rashes commonly occur on the scalp, back, and extensor surfaces of the limbs; may or may not be accompanied by itching, with recurrent rashes that often worsen in winter and improve in summer. (Traditional Chinese Medical Diagnostic Criteria): Meets the diagnostic criteria for blood heat, blood stasis, or blood dryness patterns of leukoderma as described in "TCM Dermatology and Venereology": 1) Blood heat pattern: Rashes are bright red, with layered scales; after removing the scales, pinpoint bleeding occurs; severe itching, constipation, and dark urine; red tongue with thin yellow coating, wiry slippery or rapid pulse. 2) Blood stasis pattern: Rashes persist without healing, with thick and adherent scales; rashes are dark red, thickened, and infiltrated, forming plaques; purple tongue with ecchymoses, thready or slow pulse. 3) Blood dryness pattern: Long-standing disease course; rashes are pale red, with fewer scales, dry and fissured; accompanied by itching and dryness of the throat and mouth; pale red tongue with little coating, deep and fine pulse. (2) Psoriasis Area and Severity Index (PASI) score =10 and Dermatology Life Quality Index (DLQI) score =10; (3) Age between 18 and 60 years; (4) Patients voluntarily agree to participate, have good compliance, can adhere to the treatment regimen, and attend follow-ups on time.
Exclusion criteria
Exclusion criteria: (1) With severe diseases of major organs such as heart, liver, or kidney, including active pulmonary tuberculosis or cardio-renal insufficiency; (2) Patients allergic to the investigational drug in this study; (3) Pregnant or breastfeeding women; (4) Patients with other severe skin diseases, such as skin tumors or photosensitive skin diseases; (5) Patients who have used systemic glucocorticoids, immunosuppressants, retinoids, or other immunomodulators (e.g., methylprednisolone, acitretin, methotrexate, cyclosporine) within the past 2 months, or have used topical glucocorticoids, retinoids, or other immunomodulatory drugs within the past month, or have undergone phototherapy; (6) Patients taking medications that may exacerbate psoriasis (e.g., potassium supplements, beta-blockers); (7) Patients currently participating in other clinical drug trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficient; | — |
Secondary
| Measure | Time frame |
|---|---|
| Psoriasis Area and Severity Index (PASI);Quality of Life Observation Index (DLQI);TCM Syndrome Score; | — |
Countries
China
Contacts
Public ContactSun Shu Na
Shandong University of Traditional Chinese Medicine Affiliated Hospital
Outcome results
None listed