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Therapeutic Effects of Silymarin in Patients With B-thalassemia Major

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2009 by Isfahan University of Medical Sciences.
Recruitment status was:  Active, not recruiting
Madaus Inc
Information provided by:
Isfahan University of Medical Sciences Identifier:
First received: October 20, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
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.

Condition Intervention Phase
Beta-thalassemia Major Iron Overload Drug: Silymarin (LEGALON) Drug: Placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combined Therapy of Silymarin and Desferrioxamine in Patients With B-thalassemia Major: a Randomized Double-blind Clinical Trial

Resource links provided by NLM:

Further study details as provided by Isfahan University of Medical Sciences:

Primary Outcome Measures:
  • Serum ferritin level [ Time Frame: after 3 months and 6 months from beginning of the trial ]

Secondary Outcome Measures:
  • Liver enzymes (SGOT, SGPT, Alkaline Phosphatase), serum Hepcidin, and soluble transferrin receptor levels [ Time Frame: At the beginning and the end of the trial ]

Estimated Enrollment: 140
Study Start Date: March 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Silymarin (LEGALON) 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 Comparator: Placebo Drug: Placebo


Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00999349

Iran, Islamic Republic of
Isfahan University of Medical Sciences
Isfahan, Iran, Islamic Republic of, 81744-176
Sponsors and Collaborators
Isfahan University of Medical Sciences
Madaus Inc
Principal Investigator: Behjat Moayedi, Professor Isfahan University of Medical Sciences,
  More Information

Additional Information:
Responsible Party: Professor Behjat Moayedi, Isfahan University of Medical Sciences Identifier: NCT00999349     History of Changes
Other Study ID Numbers: 187050
Study First Received: October 20, 2009
Last Updated: October 20, 2009

Keywords provided by Isfahan University of Medical Sciences:
iron overload condition
regular desferrioxamine administration
receiving continuous blood transfusions

Additional relevant MeSH terms:
Iron Overload
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hematologic Diseases
Genetic Diseases, Inborn
Iron Metabolism Disorders
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Iron Chelating Agents
Chelating Agents
Sequestering Agents processed this record on August 17, 2017