Effect of Osveral on iron overload in beta thalassemia major patients.
Phase 2
- Conditions
- beta thalassemia.beta thalassemia
- Registration Number
- IRCT2015102524679N2
- Lead Sponsor
- Investigator
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 69
Inclusion Criteria
equal or more than 2 years old; normal creatinine level; no proteinuria; negative for hepatitis B and C or HIV; hepatic transaminase less than 5 time above normal values; nornal CBC; No cardiac disorder; the ferritin level more than 1000; transfusion more than 10 times.
Exclusion criteria: severe heart failure; patients who can not tolerate MRI; keeping liver transaminase more than five folds; repeated cytopenia; nausea and vomiting; skin rashes; and elevated serum creatinine.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Serum ferritin. Timepoint: before the intervention and every 3 monthes. Method of measurement: ELISA method, ng/ml.;The liver iron overloads. Timepoint: at the biginning of the intervention and after 12 monthes. Method of measurement: MRI T2.;The heart iron overloads. Timepoint: at the biginning of the intervention and after 12 monthes. Method of measurement: MRI T2.
- Secondary Outcome Measures
Name Time Method AST. Timepoint: at the biginning of the study and every 3 monthes. Method of measurement: Specterophotometery method, mIU/l.;ALT. Timepoint: at the biginning of the study and every 3 monthes. Method of measurement: Specterophotometery method, mIU/l.;Serum Creatinin. Timepoint: at the biginning of the study and every 3 monthes. Method of measurement: Jaffeh method, mg/dl.;Urine Creatinin. Timepoint: at the biginning of the study and every 3 monthes. Method of measurement: mg/dl.;Urine Pr. Timepoint: at the biginning of the study and every 3 monthes. Method of measurement: mg/dl.