Therapeutic Effects of Silymarin in Patients With B-thalassemia Major

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Isfahan University of Medical Sciences.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Madaus Inc
Information provided by:
Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00999349
First received: October 20, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00999349

Locations
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
Investigators
Principal Investigator: Behjat Moayedi, Professor Isfahan University of Medical Sciences, moayedi@med.mui.ac.ir
  More Information

Additional Information:
Publications:
Responsible Party: Professor Behjat Moayedi, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT00999349     History of Changes
Other Study ID Numbers: 187050, LE13K0.52,, IRCT138804022067N1
Study First Received: October 20, 2009
Last Updated: October 20, 2009
Health Authority: Iran:Isfahan University of Medical Sciences

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

Additional relevant MeSH terms:
Beta-Thalassemia
Thalassemia
Iron Overload
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Iron Metabolism Disorders
Metabolic Diseases
Deferoxamine
Silymarin
Siderophores
Iron Chelating Agents
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antioxidants
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014