Immune Abnormalities
Conditions
Keywords
Focus, immunomodulatory effect, of silymarin, on cell mediated immunity, Beta-Thalassemia, major patients.
Brief summary
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.
Interventions
DRUGDesferrioxamine, Legalon® (Silymarin)
Desferrioxamine (Novartis Pharma AG, Switzerland) at the dose of 40 mg/Kg/day and Legalon® tablets (Madaus Pharma, Italy)
Sponsors
Shiraz University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in T cell proliferation | 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 | 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 | 12 weeks | The concentrations of IL-2, IL-4, and IFN-gamma in supernatant of activated T cells were measured using ELISA assay. |
Countries
Iran
Outcome results
None listed