Phase II Study of the Effect of Senna Alexandrina Mill. on Uremic Pruritus and Serum IL-2, INF-δ and TNF-α Levels of Hemodialysed Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Severity of Pruritis, as measured by a visual analogue scale
研究概览
简要总结
Uremic pruritus remains one of the most frustrating and potentially disabling symptoms in patients with end stage renal disease. It affect up to 90 percent of patients with end stage renal disease. Several hypotheses have been postulated for the possible underlying etiology, but none is conclusive. Aside from kidney transplantation, which is only definitive treatment, therapeutic approaches have largely been empirical, and no firm evident-base treatments are available. The main goal of therapy remains to minimize severity of pruritus. In Iranian traditional medicine Cassia senna L. is used for healing uremic pruritus . In this study investigators considered to evaluate effect of Cassia senna L. in uremic pruritus by a double blind placebo control clinical trial. It is hypothesized that oral Cassia senna L. may attenuate uremic pruritus by decreasing serum IL-2, IFN-γ and TNF-α.
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 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hemodialysis patients
- •Suffering from pruritus for at least 6 weeks
- •Have not responded to other drugs
排除标准
- •Dermatological disease
- •Liver disease
- •Metabolic disease
研究组 & 干预措施
Placebo
Wheat
干预措施: Placebo (Drug)
Senna
Senna
干预措施: Senna (Drug)
结局指标
主要结局
Severity of Pruritis, as measured by a visual analogue scale
时间窗: 3 months
A '0' score represented absence of pruritus and a '10' represented the greatest severity of symptoms.
次要结局
- Serum IL-2 level(3 months)
研究者
Pouya Faridi
Dr.
Shiraz University of Medical Sciences
