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临床试验/NCT02008864
NCT02008864已完成不适用

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

Shiraz University of Medical Sciences0 个研究点目标入组 60 人开始时间: 2011年8月最近更新:
适应症
干预措施
相关药物

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

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

Placebo Comparator

Wheat

干预措施: Placebo (Drug)

Senna

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pouya Faridi

Dr.

Shiraz University of Medical Sciences

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