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A randomized, double-blind and crossover trial was performed on 70 beta thalassemia patients at the Thalassemia Research Center in Mazandaran University of Medical Sciences. The aim of this study was determination of silymarin effects on serum ferritin and iron levels in comparison with placebo in β-thalassemia patients undergoing iron chelation therapy. This study had been designed in three phases. During the first phase, patients were received silymarin tablet (420 mg - three times a day) or placebo tablet (three times a day) for 12-weeks. Phase 2 was a washout phase during 2-weeks. During phase 3, patients who randomly were assigned to receive silymarin were changed to receive placebo. Also, patients randomly were assigned to receive placebo during phase 1 were changed to receive silymarin. Serum iron, ferritin, and TIBC were measured immediately before and after each period. Change of treatment regimen was exclusion criteria during study.