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NCT Number: NCT01001845

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

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.

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Key information

Conditions

Hemodialysis Chronic Disease Disease Attributes End Stage Renal Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nemazi Hospital

Shiraz, Fars, 71345, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Milk Thistle extract

Drug

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

Vit E

Drug

200 mg twice daily for 3 weeks

vit E + Milk Thistle extract

Drug

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

Primary outcomes

  1. RBC Glutathion Peroxidase level

    Time frame: 3 weeks

Secondary outcomes

  1. Plasma malondialdehyde

    Time frame: 3 weeks

Sponsors and collaborators

Lead sponsor

Shiraz University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 27, 2009
Registry last updated
Jan 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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