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Trial record 96 of 595 for:    reduced glutathione

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01001845
Recruitment Status : Completed
First Posted : October 27, 2009
Last Update Posted : January 24, 2011
Sponsor:
Information provided by:
Shiraz University of Medical Sciences

Tracking Information
First Submitted Date  ICMJE October 26, 2009
First Posted Date  ICMJE October 27, 2009
Last Update Posted Date January 24, 2011
Study Start Date  ICMJE June 2009
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 26, 2009)
RBC Glutathion Peroxidase level [ Time Frame: 3 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01001845 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2009)
Plasma malondialdehyde [ Time Frame: 3 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparative Effects of Milk Thistle Extract With Vitamin-E in Hemodialysis Patients
Official Title  ICMJE Comparative Effects of Milk Thistle Extract With Vitamin-E on Oxidative Stress Biomarkers in Hemodialysis Patients
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Hemodialysis
  • End Stage Renal Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • No Intervention: Lifestyle counseling
  • Active Comparator: vit E
    200mg 2 times per day for 3 weeks
    Intervention: Drug: vit E
  • Experimental: Milk Thistle extract
    1 tablet (equivalent to 140 mg silymarin) 3 times a day for 3 weeks
    Intervention: Drug: Milk Thistle extract
  • 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
    Intervention: Drug: vit E + Milk Thistle extract
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: October 26, 2009)
80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01001845
Other Study ID Numbers  ICMJE 53001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Jamshid Roozbeh, Nephrology and Urology Research Center
Study Sponsor  ICMJE Shiraz University of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Shiraz University of Medical Sciences
Verification Date September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP