Therapeutic Effects of Silymarin in Patients With B-thalassemia Major

Isfahan University of Medical Sciences

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Beta-thalassemia Major; Iron Overload

Treatments: Drug: Placebo; Drug: Silymarin (LEGALON)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00999349

IRCT138804022067N1

LE13K0.52,

187050

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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140 participants in 2 patient groups, including a placebo group

Silymarin (LEGALON)

Experimental group

Treatment:

Drug: Silymarin (LEGALON)

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo