Beta-Thalassemia major. Beta-Thalassemia major
Conditions
Interventions
Intervention 1: Silymarin Capsule, 140 mg, 3 times a day + desferal 50 mg/kg. Intervention 2: Placebo capsules Similar to Silymarin + desferal injection 50 mg/kg.
Treatment - Drugs
Placebo
Silymarin Capsule, 140 mg, 3 times a day + desferal 50 mg/kg
Placebo capsules Similar to Silymarin + desferal injection 50 mg/kg
Sponsors
Isfahan University of Medical Sciences
ROTTAPHARM | MADAUS
Eligibility
Sex/Gender
All
Age
12 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion Criteria: Presence of major Beta-thalassemia, age 12 years or older, iron overload condition (with serum ferritin levels between 1000-5000 ng/mL) during 6 months prior to study, regular deferoxamine administration (50 mg/kg), receiving continuous blood transfusions maintained at a hemoglobin level of 9.5 g/dl, negative CRP test at the beginning of the study Exclusion criteria: Presence of hepatitis B or C infection, positive HIV test, gastrointestinal problemss preventing absorption of an oral medication presence of chronic renal or heart failure, iron chelating therapy with iron chelators other than desferrioxamine, pregnancy
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum ferritin. Timepoint: 3 months and 6 months from beginning of the trial. Method of measurement: ELISA assay.;Liver enzymes (SGOT, SGPT, Alkaline Phosphatase). Timepoint: 3 months and 6 months from beginning of the trial. Method of measurement: ELISA assay. | — |
Countries
Iran (Islamic Republic of)
Outcome results
None listed