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

This study has been completed.
Information provided by:
Shiraz University of Medical Sciences Identifier:
First received: October 26, 2009
Last updated: January 21, 2011
Last verified: September 2010

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.

Condition Intervention Phase
End Stage Renal Disease
Drug: Milk Thistle extract
Drug: vit E
Drug: vit E + Milk Thistle extract
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Comparative Effects of Milk Thistle Extract With Vitamin-E on Oxidative Stress Biomarkers in Hemodialysis Patients

Resource links provided by NLM:

Further study details as provided by Shiraz University of Medical Sciences:

Primary Outcome Measures:
  • RBC Glutathion Peroxidase level [ Time Frame: 3 weeks ]

Secondary Outcome Measures:
  • Plasma malondialdehyde [ Time Frame: 3 weeks ]

Estimated Enrollment: 80
Study Start Date: June 2009
Study Completion Date: May 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Lifestyle counseling
Active Comparator: vit E
200mg 2 times per day for 3 weeks
Drug: vit E
200 mg twice daily for 3 weeks
Experimental: Milk Thistle extract
1 tablet (equivalent to 140 mg silymarin) 3 times a day for 3 weeks
Drug: Milk Thistle extract
1 tablet equivalent to 140 mg of silymarin, 3 times daily for 3 weeks
Experimental: vit E + Milk Thistle Extract
200mg vit E twice a day + 1 tablet of Milk Thistle extract 3 times a day 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


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01001845

Iran, Islamic Republic of
Nemazi Hospital
Shiraz, Fars, Iran, Islamic Republic of, 71345
Sponsors and Collaborators
Shiraz University of Medical Sciences
Study Director: Ghazal Vessal, PharmD, PhD Shiraz University of Medical Sciences, Faculty of Pharmacy
Principal Investigator: Bahram Shahriari, MD Shiraz University of Medical Sciences
Study Chair: Jamshid Roozbeh, MD Nephrology Urology Research Center, Shiraz University of Medical Sciences
Principal Investigator: masoumeh Akmali, PhD Shiraz University of Medical Sciences
  More Information

Responsible Party: Dr. Jamshid Roozbeh, Nephrology and Urology Research Center Identifier: NCT01001845     History of Changes
Other Study ID Numbers: 53001
Study First Received: October 26, 2009
Last Updated: January 21, 2011

Keywords provided by Shiraz University of Medical Sciences:
oxidative stress
plasma malondialdehyde
Glutathion peroxidase

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Vitamin E
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Growth Substances processed this record on April 24, 2017