ITMCTR2000003934尚未招募未知
A multicenter, randomized, double-blind, placebo-controlled study based on cooling blood latent Yang method combined with biological agents on the impact in recurrence of plaque psoriasis
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 性别
- All
入选标准
- •1) Diagnostic criteria of western medicine for plaque psoriasis and the diagnostic criteria of TCM syndromes of blood heat syndrome;
- •2) PGA >= 3, PASI >= 12, and BSA >= 10% at screening and baseline;
- •3) Aged 18 and 65 years;
- •4) Consent to participate in the research study and sign the informed consent form.
排除标准
- •1) Patients with pustular psoriasis,arthrotype, erythroderma psoriasis and / or drip psoriasis;
- •2) Any clinically active skin diseases other than moderate to severe psoriasis vulgaris which might counter or influence the study aim;
- •3) Patients who used any of the following systemic treatments within 4 weeks before the Baseline visit eg: drugs for other studys, immuno-suppressive drugs, biologics;
- •4) Patients who used topical treatment within 2 weeks before the Baseline visit eg corticosteroids ultraviolet-light therapy including sunbathing;
- •5) Active infectious disease which was hard to control;
- •6) People infected with tuberculosis;
- •7) Patients with viral hepatitis;
- •8) History of severe systemic disease. Or the clinical test index is one of the following: the ALT or the AST is higher than 1.5 times the normal value limit; the creatinine(Cr) is higher than 1.5 times the normal value limit; anyone of the main blood indicators (white blood cells count, red blood cells count, hemoglobin, platelet count) is lower than normal lower limit;or patients with other abnormal laboratory tests that the researchers judged unfit to participate in the trial;
- •9) A history of cancer and patients with primary or secondary immunodeficiency and hypersensitivity;
- •10) Participate in other clinical trials within 3 months prior to the baseline;
- •11) Received a major operation within 8 weeks prior to the baseline or study period;
- •12) Women who have fertility refusal to adopt contraception from the screening period to the last time after the end of the drug delivery;
- •13) Pregnancy or lactation;
- •14) Subjects with smokehard-drinkingtake drugs and drug abuse;
- •15) Subjects with history or family history of severe psychosis;
- •16) Other subjects judged by the investigator to be ineligible for enrollment.
研究者
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