Therapeutic Effects of Silymarin in Patients With B-thalassemia Major

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. 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
Madaus Inc
Information provided by:
Isfahan University of Medical Sciences

October 20, 2009
October 21, 2009
October 21, 2009
March 2009
December 2009   (Final data collection date for primary outcome measure)
Serum ferritin level [ Time Frame: after 3 months and 6 months from beginning of the trial ]
Same as current
No Changes Posted
Liver enzymes (SGOT, SGPT, Alkaline Phosphatase), serum Hepcidin, and soluble transferrin receptor levels [ Time Frame: At the beginning and the end of the trial ]
Same as current
Not Provided
Not Provided
Therapeutic Effects of Silymarin in Patients With B-thalassemia Major
Combined Therapy of Silymarin and Desferrioxamine in Patients With B-thalassemia Major: a Randomized Double-blind Clinical Trial
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.
Not Provided
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Beta-thalassemia Major
  • Iron Overload
  • 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
  • Experimental: Silymarin (LEGALON)
    Intervention: Drug: Silymarin (LEGALON)
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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 Identifier (NCT Number) in Medline.
Unknown status
Same as current
Not Provided
December 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
Not Provided
Not Provided
Not Provided
Professor Behjat Moayedi, Isfahan University of Medical Sciences
Isfahan University of Medical Sciences
Madaus Inc
Principal Investigator: Behjat Moayedi, Professor Isfahan University of Medical Sciences,
Isfahan University of Medical Sciences
October 2009

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