Anti-Inflammation & Vascular Endothelial Protection Effects of Dextromethorphan on Heavy Smoker
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Endothelial function
研究概览
简要总结
To test the hypothesis that DM could have anti-inflammatory effect and thus achieve vascular protection effect on heavy smokers.
详细描述
Dextromethorphan (DM), an ingredient widely used in antitussive remedies, had been reported to reduce the inflammation-mediated degeneration of neurons. We recently found that DM can prevent vascular remodeling and neuron injury in animal models of carotid ligation and cerebral ischemia injuries, respectively. It was believed that its action was through the anti-oxidant and NADPH pathway to protect brain cells. However, the mechanism and actual effect on human vascular protection remained unclear.
To test the hypothesis that DM could have anti-inflammatory effect and thus achieve vascular protection effect on heavy smokers, this prospective study will be conducted to treat subjects with heavy smoking history with DM or not and evaluate the anti-inflammatory and the improvement of endothelial function.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •healthy male volunteers who are currently smoking
排除标准
- •personal history of hypertension or diabetes mellitus
- •family history with
- •documented premature cardiovascular events
- •cardiovascular-associated sudden death
- •total cholesterol > 240 mg/dL
- •triglyceride > 200 mg/dL
- •low-density lipoprotein > 160 mg/dL.
研究组 & 干预措施
1
干预措施: Dextromethorphan (Drug)
结局指标
主要结局
Endothelial function
时间窗: 1, 2, 3 and 6 month
次要结局
- Surrogate end-points of the study: hs-CRP, sPLA2, matrix metalloproteinase-3, interleukin-6, tumor necrosis factor-alfa receptor II, GSH-Px, and urinary excretion of 8-PGF2alfa(1, 2, 3 and 6 months)