Overview

This trial is active, not recruiting.

Conditions beta-thalassemia major, iron overload
Treatments silymarin (legalon), placebo
Phase phase 2/phase 3
Sponsor Isfahan University of Medical Sciences
Collaborator Madaus Inc
Start date March 2009
End date December 2009
Trial size 140 participants
Trial identifier NCT00999349, 187050, IRCT138804022067N1, LE13K0.52,

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics/dynamics study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
silymarin (legalon)
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
(Placebo Comparator)
placebo

Primary Outcomes

Measure
Serum ferritin level
time frame: after 3 months and 6 months from beginning of the trial

Secondary Outcomes

Measure
Liver enzymes (SGOT, SGPT, Alkaline Phosphatase), serum Hepcidin, and soluble transferrin receptor levels
time frame: At the beginning and the end of the trial

Eligibility Criteria

Male or female participants at least 12 years old.

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

Additional Information

Official title Combined Therapy of Silymarin and Desferrioxamine in Patients With B-thalassemia Major: a Randomized Double-blind Clinical Trial
Principal investigator Behjat Moayedi, Professor
Trial information was received from ClinicalTrials.gov and was last updated in October 2009.
Information provided to ClinicalTrials.gov by Isfahan University of Medical Sciences.