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Therapeutic Effects of Silymarin in Patients With B-thalassemia Major

Primary Purpose

Beta-thalassemia Major, Iron Overload

Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Silymarin (LEGALON)
Placebo
Sponsored by
Isfahan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Beta-thalassemia Major focused on measuring iron overload condition, regular desferrioxamine administration, receiving continuous blood transfusions

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Isfahan University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Silymarin (LEGALON)

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Serum ferritin level

Secondary Outcome Measures

Liver enzymes (SGOT, SGPT, Alkaline Phosphatase), serum Hepcidin, and soluble transferrin receptor levels

Full Information

First Posted
October 20, 2009
Last Updated
October 20, 2009
Sponsor
Isfahan University of Medical Sciences
Collaborators
Madaus Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00999349
Brief Title
Therapeutic Effects of Silymarin in Patients With B-thalassemia Major
Official Title
Combined Therapy of Silymarin and Desferrioxamine in Patients With B-thalassemia Major: a Randomized Double-blind Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Unknown status
Study Start Date
March 2009 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Isfahan University of Medical Sciences
Collaborators
Madaus Inc

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Beta-thalassemia Major, Iron Overload
Keywords
iron overload condition, regular desferrioxamine administration, receiving continuous blood transfusions

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Silymarin (LEGALON)
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Silymarin (LEGALON)
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Serum ferritin level
Time Frame
after 3 months and 6 months from beginning of the trial
Secondary Outcome Measure Information:
Title
Liver enzymes (SGOT, SGPT, Alkaline Phosphatase), serum Hepcidin, and soluble transferrin receptor levels
Time Frame
At the beginning and the end of the trial

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Behjat Moayedi, Professor
Organizational Affiliation
Isfahan University of Medical Sciences, moayedi@med.mui.ac.ir
Official's Role
Principal Investigator
Facility Information:
Facility Name
Isfahan University of Medical Sciences
City
Isfahan
ZIP/Postal Code
81744-176
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
19453758
Citation
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.
Results Reference
background
Links:
URL
http://www.irct.ir/
Description
Iranian Registry of Clinical Trials

Learn more about this trial

Therapeutic Effects of Silymarin in Patients With B-thalassemia Major

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