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临床试验/NCT01001845
NCT01001845已完成2 期

Comparative Effects of Milk Thistle Extract With Vitamin-E on Oxidative Stress Biomarkers in Hemodialysis Patients

Shiraz University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2009年6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
入组人数
80
试验地点
1
主要终点
RBC Glutathion Peroxidase level

研究概览

简要总结

For end-stage renal disease (ESRD) patients, cardiovascular disease remains the single most common cause of excess morbidity and mortality. Among the examined nontraditional risk factors, an increase in oxidative stress as well as inflammation are postulated to contribute to excessive cardiovascular risk in this population.

Flavonoids are naturally occurring substances that possess various pharmacological actions and therapeutic applications. Some due to their phenolic structures have antioxidant effect and inhibit free radical-mediated processes, as well as anti-inflammatory effects. Silymarin,a mixture of three isomeric flavonolignans, is isolated from milk thistle (Silybum marianum) seeds, and is proven to have anti-oxidant, anti-inflammatory, cell regenerating, and antifibrotic action.

In this study, the effect of silymarin on oxidative stress and inflammation (2 major risk factors for cardiovascular morbidity and mortality in hemodialysis patients)is evaluated, and compared to vit E, a well known antioxidant.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • All hemodialysis patients age 18-60
  • On hemodialysis for over 3 months, 3 times a week, and for 4 hours each time
  • Signed informed consent

排除标准

  • Heart Failure NYHA Class III or IV
  • Recent MI (within 1 year)
  • Use of anti-oxidant supplements: N-acetyl-cystein, Omega 3, Vit C, Vit E, green tea, soy extracts, pomegranate extract, grape extract..
  • Hepatitis B or C
  • Active Infection
  • Psychiatric illness
  • Active malignancy

研究组 & 干预措施

vit E

Active Comparator

200mg 2 times per day for 3 weeks

干预措施: vit E (Drug)

Milk Thistle extract

Experimental

1 tablet (equivalent to 140 mg silymarin) 3 times a day for 3 weeks

干预措施: Milk Thistle extract (Drug)

vit E + Milk Thistle Extract

Experimental

200mg vit E twice a day + 1 tablet of Milk Thistle extract 3 times a day for 3 weeks

干预措施: vit E + Milk Thistle extract (Drug)

结局指标

主要结局

RBC Glutathion Peroxidase level

时间窗: 3 weeks

次要结局

  • Plasma malondialdehyde(3 weeks)

研究者

申办方类型
Other

研究点 (1)

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