drugset / Trial / NCT00999349

Therapeutic Effects of Silymarin in Patients With B-thalassemia Major

NCT00999349

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2009-03
Primary completion
2009-12
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Silymarin Traditional medicine (herbal / TCM) 140 mg Oral
Background Deferoxamine Other / unclassified 50 mg/kg Other