Psoriasis
Conditions
Interventions
Treatment group:Wushezhiyang Pills(oral administration)
Control group:placebo(oral administration)
Sponsors
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18 to 65 years (inclusive), of either sex; (2) Meeting the Western medicine diagnostic criteria for plaque psoriasis; (3) Skin lesions in the stable (stationary) stage; (4) Meeting the diagnostic criteria for Blood-Dryness Syndrome () according to Traditional Chinese Medicine (TCM) pattern differentiation; (5) Body Surface Area (BSA) involvement =3%, Psoriasis Area and Severity Index (PASI) score =3, and Dermatology Life Quality Index (DLQI) score =6; (6) Willing to participate voluntarily and having signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Subjects with psoriasis who have a tendency toward erythroderma, or who are in the progressive stage with rapidly advancing skin lesions; (2) Subjects who plan to become pregnant within 1 year, or who are pregnant or lactating; (3) Subjects with severe primary diseases involving the circulatory, respiratory, digestive, urinary, endocrine, or hematopoietic systems that cannot be controlled by conventional treatment and remain unstable; or subjects with concurrent malignancies; or subjects with severe infection; or subjects with fluid, electrolyte, or acid-base disturbances; or subjects with clinically significant abnormalities in safety laboratory parameters, defined as follows: Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5× the upper limit of normal (ULN); Creatinine >1.5× ULN; Hemoglobin exceeding the ULN by >20 g/L; Platelet count 75.0×10^9 ·L^-1; White blood cell count 5.5 mmol/L^-1or <3.0 mmol/L^-1; Or any other laboratory abnormality that is clinically significant and, in the investigator's judgment, makes the subject unsuitable for participation; (4) Subjects with a history of allergy to any of the investigational products used in this study; (5) Subjects who require concomitant administration of medications containing Veratrum (Lilu), Trogopterus dung (Wulingzhi), or Gleditsia (Zaojia); (6) Subjects who have participated in another drug clinical trial within the past 1 month or are currently participating in another drug clinical trial; (7) Subjects who have used biologics within 24 weeks, or who have received conventional systemic therapies (e.g., methotrexate, acitretin capsules, cyclosporine) within 4 weeks, or who have received phototherapy within 4 weeks, or who have used topical corticosteroids, topical retinoids, topical Chinese herbal medicines, or acupuncture within 2 weeks; (8) Subjects with poor compliance, for example, those without a caregiver or whose caregiver is unable to assist them in correctly using the study drug, or unable to accurately report changes in their condition and complete follow-up assessments; (9) Subjects with any other special conditions that, in the investigator's opinion, make them unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in Psoriasis Area and Severity Index(PASI) score from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage improvement in PASI score; Body Surface Area (BSA) score;Visual Analogue Scale score for pruritus;Dermatology Life Quality Index(DLQI) score; | — |
Countries
China
Contacts
Public ContactSongPing
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Outcome results
None listed