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

NCT01001845 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2011-01-24

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Shiraz University of Medical Sciences

    lead OTHER

Principal Investigators

  • Ghazal Vessal, PharmD, PhD · Shiraz University of Medical Sciences, Faculty of Pharmacy

  • Bahram Shahriari, MD · Shiraz University of Medical Sciences

  • Jamshid Roozbeh, MD · Nephrology Urology Research Center, Shiraz University of Medical Sciences

  • masoumeh Akmali, PhD · Shiraz University of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2010-03-31
Completion
2010-05-31

Countries

  • Iran

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01001845 on ClinicalTrials.gov