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临床试验/NCT02463318
NCT02463318已完成不适用

The Effect of Melatonin on Gene Expression and Activity of the Sirt1 and Its Target Genes Catalase and MnSOD in Multiple Sclerosis Patients and Healthy Subjects

Tehran University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2012年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
1
主要终点
Relative gene expression by real-time PCR (polymerase chain reaction)

研究概览

简要总结

The purpose of this study is to investigate the gene expression and activity of SIRT1, and forkhead box O3 pathway by means of investigating target genes MnSOD and catalase in multiple sclerosis and healthy subjects. Also, we investigate the effect of melatonin on interaction between SIRT1 activity and target genes MnSOD and catalase in multiple sclerosis and healthy subject .Additionally, we evaluate effect the probable effect of melatonin treatment on gene expression and activity of above-mentioned genes in peripheral blood mononuclear cells of healthy subjects-treated with H2O2.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • patients with relapsing-remitting multiple sclerosis. The diagnosis of MS was based on the McDonald criteria . All patients were newly diagnosed cases with an Expanded Disability Status Scale (EDSS) score ≤ 6 and had never received immunomodulatory and immunosuppressive drugs.

排除标准

  • The exclusion criteria were as follows: 1) treated with antioxidant supplements, anti-inflammatory drugs, and vitamins in the previous 6 months; 2) had a history of acute or chronic infection, malignancy, diabetes (type I and II), and any clinically significant systemic disease; 3) was currently pregnant or lactating; 4) was currently smoking; 5) used contraceptive medication during the previous 6 months.

研究组 & 干预措施

Healthy subjects

Experimental

Melatonin,one millimolar,one micromolar,one nanomolar, 12 hr treatment. hydrogen peroxide, 250 micromollar,2 hr treatment

干预措施: Hydrogen peroxide (Other)

Multiple slerosis

Experimental

Melatonin,,one millimolar,one micromolar,one nanomolar, 12 hr treatment.

干预措施: Melatonin (Drug)

Healthy subjects

Experimental

Melatonin,one millimolar,one micromolar,one nanomolar, 12 hr treatment. hydrogen peroxide, 250 micromollar,2 hr treatment

干预措施: Melatonin (Drug)

结局指标

主要结局

Relative gene expression by real-time PCR (polymerase chain reaction)

时间窗: Change from baseline after 12-hour treatment with melatonin and 2 -hours treatment with H2O2

次要结局

  • SIRT1 enzyme activity assay(Change from baseline after 12-hour treatment with melatonin and 2 -hours treatment with H2O2)
  • MnSOD enzyme activity assay(Change from baseline after 12-hour treatment with melatonin and 2 -hours treatment with H2O2)
  • Catalse enzyme activity assay(Change from baseline after 12-hour treatment with melatonin and 2 -hours treatment with H2O2)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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