NCT01443338Unknown4 期
A Phase4,Multicenter, Randomized,Double-blind,Double Dummy, Parallel Controlled Study Evaluating the Efficacy and Safety of Triptergium Wilfordii and Acitretin in Treatment of Chinese Patients With Moderate to Severe Psoriasis Vulgaris
Ministry of Health, China1 个研究点 分布在 1 个国家目标入组 720 人开始时间: 2011年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 720
- 试验地点
- 1
- 主要终点
- Change from baseline in plaque psoriasis as assessed by PASI(psoriasis area and severity index) response or PASI 75 (a patient that has an improvement from baseline PASI of at least 75%)
研究概览
简要总结
The purpose of this study is to determine whether Triptergium wilfordii, and Acitretin are effective and safe in the treatment of patient of moderate to severe psoriasis vulgaris.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults of both sexes, between the age 18 and 75 years.
- •Have a diagnosis of psoriasis vulgaris,PASI score of 7 or greater.
- •Capable of giving informed consent and the consent must be obtained prior to any study related procedures.
排除标准
- •Currently have erythrodermic,guttate or pustular psoriasis.
- •Have any active dermatoses which may affect disease assessment of psoriasis.
- •Have used any investigational drug,any biologic or any systemic immunosuppressants within the previous 1 month..
- •Have used topical medications/treatments that could affect psoriasis or PASI evaluation (eg, corticosteroids, tar, phototherapy et al.) within 2 weeks.
- •Have any acute or chronic or recurrent infectious disease,which was difficult to control.
- •Have the history of HBV or HCV infection,or HIV antibody test positive.
- •AST, ALT or blood fat levels must be within 1.5 times the ULN range for the laboratory conducting the test.
- •Are pregnant, nursing, or planning pregnancy in the coming two years(both men and women) while enrolled in the study.
- •Have any severe systemic disease or have a history of malignancy.
- •Have shown a previous hypersensitivity to Triptergium wilfordii or Acitretin.
- •Have any other condition not suitable to join in trial,which are judged by investigator.
研究组 & 干预措施
Triptergium Wilfordii
Active Comparator
a kind of traditional chinese medicine
干预措施: Triptergium Wilfordii (Drug)
Acitretin
Active Comparator
干预措施: Acitretin (Drug)
结局指标
主要结局
Change from baseline in plaque psoriasis as assessed by PASI(psoriasis area and severity index) response or PASI 75 (a patient that has an improvement from baseline PASI of at least 75%)
时间窗: to 8 weeks treatment
次要结局
- Change from baseline in plaque psoriasis as assessed by PASI response or PASI 90 (a patient that has an improvement from baseline PASI of at least 90%)(to 8 weeks treatment)
- Change from baseline in plaque psoriasis as assessed by PASI response or PASI 50 (a patient that has an improvement from baseline PASI of at least 50%)(to 8 weeks treatment)
- Laboratory parameters, rates of AEs, and percentage of patients requiring interruption or discontinuation of study drug due to AEs(to 8 weeks treatment)
研究者
Min Zheng
Head of dermatology
Second Affiliated Hospital, School of Medicine, Zhejiang University
研究点 (1)
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