Immunomodulatory Effects of Silymarin in Patients With Beta-Thalassemia Major
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|ClinicalTrials.gov Identifier: NCT01752153|
Recruitment Status : Completed
First Posted : December 19, 2012
Last Update Posted : December 19, 2012
|Condition or disease||Intervention/treatment||Phase|
|Immune Abnormalities||Drug: Desferrioxamine, Legalon® (Silymarin) Drug: Silymarin (Legalon)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||September 2012|
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)
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01752153
|Iran, Islamic Republic of|
|Department of Immunology, School of Medicine, Shiraz University of Medical Sciences|
|Shiraz, Fars, Iran, Islamic Republic of|
|Study Director:||Zahra Amirghofran, PhD||Shiraz University of Medical Sciences|