Therapeutic Effects of Silymarin in Patients With B-thalassemia Major

Phase 2

• Conditions: Beta-thalassemia Major; Iron Overload
• Interventions: Drug: Silymarin (LEGALON); Drug: Placebo

• Registration Number: NCT00999349
• Lead Sponsor: Isfahan University of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Status Verified: 2009-10
• Study First Submitted: 2009-10-20
• Study First Submitted QC: 2009-10-20
• Last Update Submitted: 2009-10-20
• Study First Posted: 2009-10-21
• Last Update Posted: 2009-10-21
• Primary Completion: 2009-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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 Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Silymarin (LEGALON)	Silymarin (LEGALON)	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Serum ferritin level	after 3 months and 6 months from beginning of the trial

Secondary Outcome Measures

Name	Time	Method
Liver enzymes (SGOT, SGPT, Alkaline Phosphatase), serum Hepcidin, and soluble transferrin receptor levels	At the beginning and the end of the trial

Trial Locations

Locations (1)

Isfahan University of Medical Sciences; 🇮🇷 Isfahan, Iran, Islamic Republic of