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

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00999349

Enrollment

140

Registered

2009-10-21

Start date

2009-03-31

Completion date

Unknown

Last updated

2009-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Beta-thalassemia Major, Iron Overload

Keywords

iron overload condition, regular desferrioxamine administration, receiving continuous blood transfusions

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.

Interventions

DRUGPlacebo

DRUGSilymarin (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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026