Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Therapeutic Effects of Silymarin in Patients With B-thalassemia Major

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00999349
Recruitment Status : Unknown
Verified October 2009 by Isfahan University of Medical Sciences.
Recruitment status was:  Active, not recruiting
First Posted : October 21, 2009
Last Update Posted : October 21, 2009
Sponsor:
Collaborator:
Madaus Inc
Information provided by:
Isfahan University of Medical Sciences

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

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

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
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
Study Start Date : March 2009
Estimated Primary Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron Thalassemia
Drug Information available for: Silymarin

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00999349


Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Behjat Moayedi, Professor Isfahan University of Medical Sciences, moayedi@med.mui.ac.ir
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications:

Layout table for additonal information
Responsible Party: Professor Behjat Moayedi, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT00999349    
Other Study ID Numbers: 187050
LE13K0.52,
IRCT138804022067N1
First Posted: October 21, 2009    Key Record Dates
Last Update Posted: October 21, 2009
Last Verified: October 2009
Keywords provided by Isfahan University of Medical Sciences:
iron overload condition
regular desferrioxamine administration
receiving continuous blood transfusions
Additional relevant MeSH terms:
Layout table for MeSH terms
Thalassemia
beta-Thalassemia
Iron Overload
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
 Genetic Diseases, Inborn
Iron Metabolism Disorders
Metabolic Diseases
Silymarin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs