drugset / Trial / NCT01001845

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

NCT01001845

Phase 2 Completed 80 enrolled Shiraz University of Medical Sciences
RandomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2009-06
Primary completion
2010-03
Completion
2010-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Silymarin Traditional medicine (herbal / TCM) 140 mg
Subject vit E Unknown 200 mg