NCT01001845

Comparative Effects of Milk Thistle Extract With Vitamin-E in Hemodialysis Patients

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Shiraz University of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hemodialysis
• End Stage Renal Disease

Interventions

Type	Name	Description
DRUG	Milk Thistle extract	1 tablet equivalent to 140 mg of silymarin, 3 times daily for 3 weeks
DRUG	vit E	200 mg twice daily for 3 weeks
DRUG	vit E + Milk Thistle extract	200 mg vit E twice daily + 1 tablet of Milk Thistle 3 times daily for 3 weeks

Timeline

• Start date: 2009-06-01
• Primary completion: 2010-03-01
• Completion: 2010-05-01
• First posted: 2009-10-27
• Last updated: 2011-01-24

Locations

1 site across 1 country: Iran