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Immunomodulatory Effects of Silymarin in Patients With Beta-Thalassemia Major

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01752153
First Posted: December 19, 2012
Last Update Posted: December 19, 2012
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.
Information provided by (Responsible Party):
Marjan Gharagozloo, Isfahan University of Medical Sciences
  Purpose
A wide spectrum of immune abnormalities has been described by numerous studies involving β-thalassemic patients with multiple transfusions. The abnormalities observed are both quantitative and functional, and concern several components of the immune response. Flavonoids are phenolic compounds widely distributed in plants, which were reported to exert multiple biological effects, including antioxidant and free radical scavenging abilities. Silymarin, a flavonolignan complex isolated from milk thistle (Silybum marianum L. Gaertn), have been classified as cytoprotective, antioxidant, anti-inflammatory, and especially as hepatoprotective agents. Silymarin is already being used clinically for treatment of liver diseases.It is considered safe and well-tolerated, with reported adverse events similar to placebo. Several studies have also reported immunomodulatory actions of silymarin. It increases lymphocyte proliferation, interferon gamma, interleukin (IL)-4 and IL-10 secretions by stimulated lymphocytes in a dose-dependent manner. It has been shown that in vitro treatment of peripheral blood mononuclear cells with silymarin causes restoration of the thiol status and increases in T cell proliferation and activation. Because reactive oxygen species and iron overload play important roles in the pathophysiology of thalassemia, silymarin may be an effective therapy due to its antioxidant, immunomodulatory, cytoprotective and iron chelating activities. The present study designed to investigate the therapeutic activity of orally administered silymarin for treatment of β-thalassemia major, a well-known and prevalent disease in Iran, which is associated with oxidative stress, iron overload and immune abnormalities.

Condition Intervention Phase
Immune Abnormalities Drug: Desferrioxamine, Legalon® (Silymarin) Drug: Silymarin (Legalon) Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change from Baseline in T cell proliferation [ Time Frame: 12 weeks ]
    PHA-activated T Cell Proliferation in Cell Culture was studied by Brdu Incorporation ELISA-based Assay

  • Changes from baseline the percentage of lymphocyte subsets [ Time Frame: 12 weeks ]
    The percentage of T cell, B cell, and NK cells were studied using flowcytometry

  • Changes from baseline the production of cytokines in activated T cells [ Time Frame: 12 weeks ]
    The concentrations of IL-2, IL-4, and IFN-gamma in supernatant of activated T cells were measured using ELISA assay.


Enrollment: 25
Study Start Date: June 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Silymarin (Legalon)
Patients who were unable or unwilling to use desferrioxamine or had stopped desferrioxamine treatment for at least 6 months, were received only silymarin.
Drug: Silymarin (Legalon)
Experimental: Combined therapy (Deaferrioxamine+Silymarin (Legalon)
In combined therapy group, patients continued desferrioxamine (Novartis Pharma AG, Switzerland) at the dose of 40 mg/Kg/day and Legalon® tablets (Madaus Pharma, Italy) was added to desferrioxamine regimen at the dose of 140 mg, taken orally, three times a day, 7 days a week.
Drug: Desferrioxamine, Legalon® (Silymarin)
Desferrioxamine (Novartis Pharma AG, Switzerland) at the dose of 40 mg/Kg/day and Legalon® tablets (Madaus Pharma, Italy)

  Eligibility

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

Inclusion Criteria:

  • Homozygous beta-thalassemia major
  • Regularly blood transfusion
  • Iron chelation therapy with subcutaneous desferrioxamine (DFO)40.0 mg/Kg/day for 5-7 days/week

Exclusion Criteria:

  • Chronic hepatitis B infection
  • Active hepatitis C infection
  • A history of a positive HIV test
  • Chronic renal or heart failure
  • Iron chelation therapy with deferiprone
  • Pregnancy
  • Gastrointestinal conditions preventing absorption of an oral medication o
  • noncompliance with prescribed therapy
  Contacts and Locations
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): NCT01752153


Locations
Iran, Islamic Republic of
Department of Immunology, School of Medicine, Shiraz University of Medical Sciences
Shiraz, Fars, Iran, Islamic Republic of
Sponsors and Collaborators
Shiraz University of Medical Sciences
Investigators
Study Director: Zahra Amirghofran, PhD Shiraz University of Medical Sciences
  More Information

Responsible Party: Marjan Gharagozloo, Assistant professor, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01752153     History of Changes
Other Study ID Numbers: 1929
First Submitted: November 21, 2012
First Posted: December 19, 2012
Last Update Posted: December 19, 2012
Last Verified: November 2012

Keywords provided by Marjan Gharagozloo, Isfahan University of Medical Sciences:
Focus
immunomodulatory effect
of silymarin
on cell mediated immunity
Beta-Thalassemia
major patients.

Additional relevant MeSH terms:
Thalassemia
beta-Thalassemia
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Silymarin
Deferoxamine
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Siderophores
Iron Chelating Agents
Chelating Agents
Sequestering Agents