Assessment of Montelukast Efficacy in the Treatment of Refractive Uremic Pruritus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 主要终点
- Change from Baseline in Detailed score proposed by Duo for pruritus
研究概览
简要总结
In this study hemodialysis patients that underwent dialysis thrice weekly screen for uremic pruritus and 80 patients that at least have refractive pruritus that lead to sleep and daily activity disorders enroll in this study. These patients should have at least a course of therapy without proper response. After proper informing patients and taking testimonial patients enter to study. Then patients randomized in case and control group. In case group, patients took montelukast 10 milligram daily and in control group took placebo for 30 days. Other antipruritic or antiinflammatory medication has been stopped one week prior to starting treatment. Calcium, phosphorous, urea, creatinine, highly sensitive CRP (hsCRP), Parathyroid Hormone (PTH), hemoglobin and kt/V were measured at beginning and at end of study. pruritus severity assessed by Detailed Pruritus Score that introduced by Duo and Visual Analogue Score in beginning and at end of study in both group. Sleep disorder score and its severity added to crude score at beginning and end of study and change of measures analyzed.
详细描述
Montelukast is an antileukotrien receptor antagonist that seems to be effective as an antipruritic medication via blocking inflammatory pathways.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hemodialysis patients that refered to dialysis centers and at least on hemodialysis thrice weekly
- •presence of uremic pruritus
- •patients that at least had refractive pruritus that lead to sleep disorders or compromised daily activities
- •patients should took a course of antipruritic treatment with no proper response
排除标准
- •presence of pruritus less than three months
- •kt/V less than 1.2
- •presence of pruritus due to other cause other than uremic state
- •presence of other pruritic diseases; malignancies; cholestasis; hepatitis B and C infection
- •treatment with corticosteroid
- •presence of anemia with hemoglobin less than 10
研究组 & 干预措施
montelukast
montelukast 10 milligram, daily for 30 days
干预措施: Montelukast (Drug)
placebo
Placebo one tablet for 30 days
干预措施: placebo (Drug)
结局指标
主要结局
Change from Baseline in Detailed score proposed by Duo for pruritus
时间窗: Change from Baseline in Detailed score at 1months
Change from Baseline in Detailed score at 1months
次要结局
- Highly sensitive CRP (hs-CRP)(Change from Baseline in serum value at 1months)
研究者
Mehdi Mahmudpour
Fellowship of Nephrology
Shiraz University of Medical Sciences