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NCT Number: NCT01752153

Immunomodulatory Effects of Silymarin in Patients With Beta-Thalassemia Major

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.

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Department of Immunology, School of Medicine, Shiraz University of Medical Sciences

Shiraz, Fars, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Desferrioxamine, Legalon® (Silymarin)

Drug

Desferrioxamine (Novartis Pharma AG, Switzerland) at the dose of 40 mg/Kg/day and Legalon® tablets (Madaus Pharma, Italy)

Silymarin (Legalon)

Drug

Primary outcomes

  1. 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

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

Shiraz University of Medical Sciences

Other

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Dec 19, 2012
Registry last updated
Dec 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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