Therapeutic Effects of Silymarin in Patients With B-thalassemia Major
This trial is active, not recruiting.
|Conditions||beta-thalassemia major, iron overload|
|Treatments||silymarin (legalon), placebo|
|Phase||phase 2/phase 3|
|Sponsor||Isfahan University of Medical Sciences|
|Start date||March 2009|
|End date||December 2009|
|Trial size||140 participants|
|Trial identifier||NCT00999349, 187050, IRCT138804022067N1, LE13K0.52,|
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.
|Endpoint classification||pharmacokinetics/dynamics study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
Serum ferritin level
time frame: after 3 months and 6 months from beginning of the trial
Liver enzymes (SGOT, SGPT, Alkaline Phosphatase), serum Hepcidin, and soluble transferrin receptor levels
time frame: At the beginning and the end of the trial
Male or female participants at least 12 years old.
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
|Official title||Combined Therapy of Silymarin and Desferrioxamine in Patients With B-thalassemia Major: a Randomized Double-blind Clinical Trial|
|Principal investigator||Behjat Moayedi, Professor|
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