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Therapeutic Effects of Silymarin in Patients With B-thalassemia Major

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ClinicalTrials.gov Identifier: NCT00999349
Recruitment Status : Unknown
Verified October 2009 by Isfahan University of Medical Sciences.
Recruitment status was:  Active, not recruiting
First Posted : October 21, 2009
Last Update Posted : October 21, 2009
Sponsor:
Collaborator:
Madaus Inc
Information provided by:
Isfahan University of Medical Sciences

Tracking Information
First Submitted Date  ICMJE October 20, 2009
First Posted Date  ICMJE October 21, 2009
Last Update Posted Date October 21, 2009
Study Start Date  ICMJE March 2009
Estimated Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 20, 2009)
Serum ferritin level [ Time Frame: after 3 months and 6 months from beginning of the trial ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2009)
Liver enzymes (SGOT, SGPT, Alkaline Phosphatase), serum Hepcidin, and soluble transferrin receptor levels [ Time Frame: At the beginning and the end of the trial ]
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 Therapeutic Effects of Silymarin in Patients With B-thalassemia Major
Official Title  ICMJE Combined Therapy of Silymarin and Desferrioxamine in Patients With B-thalassemia Major: a Randomized Double-blind Clinical Trial
Brief Summary Silymarin, a flavonolignan complex isolated from Silybum marianum, has a strong antioxidant, hepatoprotective and iron chelating activities. The present study has been designed to investigate the therapeutic activity of orally administered silymarin in patients with thalassemia major under conventional iron chelation therapy. A 6-month randomized, double-blind, clinical trial was conducted in 140 beta-thalassemia major patients in two well-matched groups. Patients are randomized to receive a silymarin tablet (140 mg) three times a day plus conventional desferrioxamine therapy or the same therapy but a placebo tablet instead of silymarin. Clinical laboratory tests of iron status and liver function are assessed at the beginning and the end of the trial.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Beta-thalassemia Major
  • Iron Overload
Intervention  ICMJE
  • Drug: Silymarin (LEGALON)
    Study group: Silymarin Capsule, 140 mg, 3 times a day + desferrioxamine injection 50 mg/kg, Placebo group:Placebo capsules Similar to Silymarin +desferrioxamine injection 50 mg/kg
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Silymarin (LEGALON)
    Intervention: Drug: Silymarin (LEGALON)
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Gharagozloo M, Moayedi B, Zakerinia M, Hamidi M, Karimi M, Maracy M, Amirghofran Z. Combined therapy of silymarin and desferrioxamine in patients with beta-thalassemia major: a randomized double-blind clinical trial. Fundam Clin Pharmacol. 2009 Jun;23(3):359-65. doi: 10.1111/j.1472-8206.2009.00681.x. Epub 2009 May 7.

*   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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 20, 2009)
140
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Presence of major Beta-thalassemia
  • Age 12 years or older
  • Iron overload condition (serum ferritin levels between 1000-5000 ng/mL) Regular desferrioxamine administration (50 mg/kg)
  • Continuous blood transfusions
  • Negative CRP test

Exclusion criteria:

  • Hepatitis B or C infection
  • Positive HIV test
  • Chronic renal or heart failure
  • Iron chelating therapy with other iron chelators
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older 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 NCT00999349
Other Study ID Numbers  ICMJE 187050
LE13K0.52,
IRCT138804022067N1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Professor Behjat Moayedi, Isfahan University of Medical Sciences
Study Sponsor  ICMJE Isfahan University of Medical Sciences
Collaborators  ICMJE Madaus Inc
Investigators  ICMJE
Principal Investigator: Behjat Moayedi, Professor Isfahan University of Medical Sciences, moayedi@med.mui.ac.ir
PRS Account Isfahan University of Medical Sciences
Verification Date October 2009

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