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临床试验/NCT01752153
NCT01752153已完成1 期

Immunomodulatory Effects of Silymarin in Patients With Beta-Thalassemia Major

Shiraz University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2012年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
25
试验地点
1
主要终点
Change from Baseline in T cell proliferation

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
12 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

Silymarin (Legalon)

Experimental

Patients who were unable or unwilling to use desferrioxamine or had stopped desferrioxamine treatment for at least 6 months, were received only silymarin.

干预措施: Silymarin (Legalon) (Drug)

Combined therapy (Deaferrioxamine+Silymarin (Legalon)

Experimental

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.

干预措施: Desferrioxamine, Legalon® (Silymarin) (Drug)

结局指标

主要结局

Change from Baseline in T cell proliferation

时间窗: 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

时间窗: 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

时间窗: 12 weeks

The concentrations of IL-2, IL-4, and IFN-gamma in supernatant of activated T cells were measured using ELISA assay.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marjan Gharagozloo

Assistant professor

Isfahan University of Medical Sciences

研究点 (1)

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