ITMCTR2026001678进行中（未招募）Unknown
A randomized, double-blind, placebo-controlled trial of Wushe Zhiyang Pills for the treatment of psoriasis and exploration of its mechanisms
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65（—）
- 性别
- All
入选标准
- •(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.
排除标准
- •(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 <3.0×10^9/L^-1;
- •Serum potassium >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.
研究者
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