Skip to content

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
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01001845
Enrollment
80
Registered
2009-10-27
Start date
2009-06-30
Completion date
2010-05-31
Last updated
2011-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Renal Disease, Hemodialysis

Keywords

hemodialysis, oxidative stress, plasma malondialdehyde, Glutathion peroxidase

Brief 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.

Interventions

1 tablet equivalent to 140 mg of silymarin, 3 times daily for 3 weeks

DRUGvit E

200 mg twice daily for 3 weeks

DRUGvit E + Milk Thistle extract

200 mg vit E twice daily + 1 tablet of Milk Thistle 3 times daily for 3 weeks

Sponsors

Shiraz University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
RBC Glutathion Peroxidase level3 weeks

Secondary

MeasureTime frame
Plasma malondialdehyde3 weeks

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026