Effect of Silymarin on Serum Ferritin and Iron Level in ß-thalassemia Patients
Phase 2
Completed
- Conditions
- Thalassaemia.Beta thalassaemia
- Registration Number
- IRCT2015101211819N2
- Lead Sponsor
- Vice chancellor for research, Mazandaran University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 70
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)
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.;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.
- Secondary Outcome Measures
Name Time Method 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.