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
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Condition or disease | Intervention/treatment | Phase |
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Immune Abnormalities | Drug: Desferrioxamine, Legalon® (Silymarin) Drug: Silymarin (Legalon) | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 25 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Study Start Date : | June 2012 |
Actual Primary Completion Date : | September 2012 |
Actual Study Completion Date : | September 2012 |

Arm | Intervention/treatment |
---|---|
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.
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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.
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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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Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

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
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 |
Responsible Party: | Marjan Gharagozloo, Assistant professor, Isfahan University of Medical Sciences |
ClinicalTrials.gov Identifier: | NCT01752153 |
Other Study ID Numbers: |
1929 |
First Posted: | December 19, 2012 Key Record Dates |
Last Update Posted: | December 19, 2012 |
Last Verified: | November 2012 |
Focus immunomodulatory effect of silymarin |
on cell mediated immunity Beta-Thalassemia major patients. |
beta-Thalassemia 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 |