Phase II Study of the Effect of Oral Cromolyn Sodium on Uremic Pruritus and Serum Tryptase Levels of Hemodialysed Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- pruritus
研究概览
简要总结
Pruritus is a major disorder among the skin derangements in advanced renal failure. Recent information suggests that interactions between dermal mast cells and distal ends of nonmyelinated C fibers may be important in the precipitation and regulation of the sensory stimuli.Patients having uremic pruritus have been noted to have increased levels of plasma histamine and tryptase as well as increased numbers of dermal mast cells.Cromolyn sodium is a mast cell stabilizing agent that inhibits degranulation of mast cells and the release of histamine, tryptase, and leukotrienes. It is hypothesized that oral cromolyn sodium may attenuate uremic pruritus by decreasing serum tryptase level.
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
- •Hemodialysis patients > 18 yo suffering from pruritus for at least 6 weeks, and who have not responded to other drugs
- •Willing and able to give informed concent
排除标准
- •Known dermatologic, liver, metabolic disease, or any other disease or condition other than ESRD that causes pruritus
- •Lactase deficiency
研究组 & 干预措施
1
Patients on hemodialysis with pruritus, receiving cromolyn sodium
干预措施: cromolyn sodium (Drug)
2
patients on hemodialysis with pruritus, receiving placebo
干预措施: placebo (Drug)
结局指标
主要结局
pruritus
时间窗: 3 months
次要结局
- serum tryptase level(4 months)
