Comparative study of efficacy of Osveral and Desferal
- Conditions
- Major thalassemia.Beta thalassaemia
- Registration Number
- IRCT201112118370N1
- Lead Sponsor
- Kermanshah university of medical sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 202
Age, more than 2 years; Type of disease, major thalassemia or intermediate that have complete medical file; Serum ferritin, when reaches upper than 1000; Number of injections, if patient has injected more than 10 times or volume of blood injection is more than 100 cc/kg; Creatinin, should not be more than normal range; Patients should be negative of HIV, HBV, HCV; Liver enzymes should be less than 5 times of normal range; Cellular blood count (CBC) should be in normal range; Patients should not have any cardiac problem and should not use any cardiac drugs & patients should have EF>55% and LVEDE<40cc/m² in echocardiography; Patients should not have visual & auditory problems; Patients should not have any proteinuria in urine analysis (Pr/Cr should not be more than 0.6mg in random urine sampling; Preferentiality, pregnant or lactiferous women should not take part in this study. Exclusion criteria: Increase of creatinin, if creatinin gets upper normal range (for age) in study or gets more than 33% of basic creatinin rate (before beginning of study); Occurrence of cardiac diseases according to annual checking (control); Occurrence of visual & auditory problems according to annual checking; If serologic tests of HIV or hepatitis gets positive according to annual checking; Increase of liver enzymes more than 5 times of the normal range; Occurrence of pancytopenia, including platelet count less than 150000/mm³ or exact count of PMN less than1500/ mm; In conditions of nausea, sever vomiting & irresponseness to antiemetics & hydration by physicians; In occurrences of sever dermal rashes & lack of recovery or progressive increase of them.
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Serum ferritin. Timepoint: 1 month. Method of measurement: Blood test.
- Secondary Outcome Measures
Name Time Method Dermatologic, gastrointestinal, liver and renal complications. Timepoint: Monthly. Method of measurement: Blood test and examination by physician.