Effect of Silymarin on Serum Ferritin and Iron Level in ß-thalassemia Patients

Authors
Category Primary study
Registry of TrialsIranian Registry of Clinical Trials
Year 2020
INTERVENTION: Intervention 1: Patients in the intervention group received 420 milligrams of silymarin tablets, three times per day. Intervention 2: Patients in the control group received placebo tablets, three times per day. Patients in the control group received placebo tablets, three times per day. Patients in the intervention group received 420 milligrams of silymarin tablets, three times per day. Placebo Treatment ‐ Drugs CONDITION: Beta thalassaemia Thalassaemia. ; Beta thalassaemia PRIMARY OUTCOME: Serum Ferritin Level. Timepoint: 1‐Before the first phase 2‐ After the washout period (after 2 weeks of the end of the first phase) 3‐ After the third phase (after 26 weeks). Method of measurement: Serum ferritin was measured by ELISA test. Serum Iron Level. Timepoint: 1‐Before the first phase 2‐ After the washout period (after 2 weeks of the end of the first phase) 3‐ After the third phase (after 26 weeks). Method of measurement: Serum Iron was measured by spectrophotometry. SECONDARY OUTCOME: Incidence of adverse drug reactions. Timepoint: 1‐Before the first phase 2‐ After the washout period (after 2 weeks of the end of the first phase) 3‐ After the third phase (after 26 weeks). Method of measurement: Data collection form. INCLUSION CRITERIA: INCLUSION CRITERIA: Patients with beta thalassemia major; History of iron chelation therapy for at least 2 years; Having relatively constant average dose of iron chelation during 3 months ago; Ferritin up to 1000 µg/L Exclusion criteria: Change therapeutic regimen with iron chelation during the study (6 months)
Epistemonikos ID: 11df8db9a19d1a3d53712f6d97bbcb17696a72d4
First added on: Apr 22, 2021