Therapeutic Effects of Silymarin in Patients With B-thalassemia Major

Iron Overload Clinical Trial

Official title:

Combined Therapy of Silymarin and Desferrioxamine in Patients With B-thalassemia Major: a Randomized Double-blind Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00999349
• Other study ID #: 187050
• Secondary ID: LE13K0.52,IRCT13
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: October 20, 2009
• Last updated: October 20, 2009
• Start date: March 2009

Study information

• Verified date: October 2009
• Source: Isfahan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran:Isfahan University of Medical Sciences
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 140
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Beta-Thalassemia
• Beta-thalassemia Major
• Iron Overload
• Thalassemia

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Isfahan University of Medical Sciences	Isfahan

Sponsors (2)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences	Madaus Inc

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum ferritin level		after 3 months and 6 months from beginning of the trial	No
Secondary	Liver enzymes (SGOT, SGPT, Alkaline Phosphatase), serum Hepcidin, and soluble transferrin receptor levels		At the beginning and the end of the trial	No

External Links

•   Iranian Registry of Clinical Trials