NCT00395941已完成2 期
Efficacy and Safety of Acitretin Plus Pioglitazone in Patients With Psoriasis
Post Graduate Institute of Medical Education and Research, Chandigarh1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2006年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in PASI score from baseline in the two groups
研究概览
简要总结
Acitretin, when given in combiantion with pioglitazone might achieve better and/or more rapid control of moderate to severe chronic plaque type psoriasis.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic plaque type psoriasis having body surface area involvement of > 20%
- •Patients of either sex
- •Females who have completed their family and are tubectomized or are postmenopausal i.e. no menstrual bleeding over at least 1 year
- •Age range 18-65 years
排除标准
- •Females of child bearing potential
- •H/O hypersensitivity to acitretin
- •Impaired hepatic function (serum bilirubin, AST, ALT and alkaline phosphatase >1.5 times the upper limit of normal)
- •Impaired renal function (serum creatinine >1.5mg% in males and >1.4 mg% in females)
- •Hyperlipidemia
- •BMI >30 kg /m2
- •H/O excessive alcohol use
- •Diabetes mellitus
- •Congestive heart failure
- •Ischemic heart disease
研究组 & 干预措施
Control
Active Comparator
Acitretin
干预措施: Acitretin (Drug)
Experimental
Experimental
Pioglitazone
干预措施: Pioglitazone (Drug)
结局指标
主要结局
Change in PASI score from baseline in the two groups
时间窗: 12 weeks
次要结局
- Proportion of subjects with an improvement of at least 75% in the psoriasis area-and-severity index (PASI) by week 12(12 weeks)
研究者
SHotra
professor
Post Graduate Institute of Medical Education and Research, Chandigarh
研究点 (1)
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