Comparative Effects of Milk Thistle Extract With Vitamin-E on Oxidative Stress Biomarkers in Hemodialysis Patients
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
- 否
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
200mg 2 times per day for 3 weeks
干预措施: vit E (Drug)
Milk Thistle extract
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
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)
