Status:
UNKNOWN
Therapeutic Effects of Silymarin in Patients With B-thalassemia Major
Lead Sponsor:
Isfahan University of Medical Sciences
Collaborating Sponsors:
Madaus Inc
Conditions:
Beta-thalassemia Major
Iron Overload
Eligibility:
All Genders
12+ years
Phase:
PHASE2
PHASE3
Brief Summary
Silymarin, a flavonolignan complex isolated from Silybum marianum, has a strong antioxidant, hepatoprotective and iron chelating activities. The present study has been designed to investigate the ther...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Presence of major Beta-thalassemia
- Age 12 years or older
- Iron overload condition (serum ferritin levels between 1000-5000 ng/mL) Regular desferrioxamine administration (50 mg/kg)
- Continuous blood transfusions
- Negative CRP test
- Exclusion criteria:
- Hepatitis B or C infection
- Positive HIV test
- Chronic renal or heart failure
- Iron chelating therapy with other iron chelators
Exclusion
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00999349
Start Date
March 1 2009
Last Update
October 21 2009
Active Locations (1)
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1
Isfahan University of Medical Sciences
Isfahan, Iran, 81744-176