Therapeutic Effects of Silymarin in Patients With B-thalassemia Major
Combined Therapy of Silymarin and Desferrioxamine in Patients With B-thalassemia Major: a Randomized Double-blind Clinical Trial
3 other identifiers
interventional
140
1 country
1
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 therapeutic activity of orally administered silymarin in patients with thalassemia major under conventional iron chelation therapy. A 6-month randomized, double-blind, clinical trial was conducted in 140 beta-thalassemia major patients in two well-matched groups. Patients are randomized to receive a silymarin tablet (140 mg) three times a day plus conventional desferrioxamine therapy or the same therapy but a placebo tablet instead of silymarin. Clinical laboratory tests of iron status and liver function are assessed at the beginning and the end of the trial.
Trial Health
Trial Health Score
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participants targeted
Target at P75+ for phase_2
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 20, 2009
CompletedFirst Posted
Study publicly available on registry
October 21, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedOctober 21, 2009
October 1, 2009
9 months
October 20, 2009
October 20, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Serum ferritin level
after 3 months and 6 months from beginning of the trial
Secondary Outcomes (1)
Liver enzymes (SGOT, SGPT, Alkaline Phosphatase), serum Hepcidin, and soluble transferrin receptor levels
At the beginning and the end of the trial
Study Arms (2)
Silymarin (LEGALON)
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Study group: Silymarin Capsule, 140 mg, 3 times a day + desferrioxamine injection 50 mg/kg, Placebo group:Placebo capsules Similar to Silymarin +desferrioxamine injection 50 mg/kg
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Hepatitis B or C infection
- Positive HIV test
- Chronic renal or heart failure
- Iron chelating therapy with other iron chelators
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Isfahan University of Medical Scienceslead
- Madaus Inccollaborator
Study Sites (1)
Isfahan University of Medical Sciences
Isfahan, 81744-176, Iran
Related Publications (1)
Gharagozloo M, Moayedi B, Zakerinia M, Hamidi M, Karimi M, Maracy M, Amirghofran Z. Combined therapy of silymarin and desferrioxamine in patients with beta-thalassemia major: a randomized double-blind clinical trial. Fundam Clin Pharmacol. 2009 Jun;23(3):359-65. doi: 10.1111/j.1472-8206.2009.00681.x. Epub 2009 May 7.
PMID: 19453758BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Behjat Moayedi, Professor
Isfahan University of Medical Sciences, moayedi@med.mui.ac.ir
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 20, 2009
First Posted
October 21, 2009
Study Start
March 1, 2009
Primary Completion
December 1, 2009
Last Updated
October 21, 2009
Record last verified: 2009-10