NCT01734707已完成3 期
Atherosclerosis Monitoring and Atherogenicity Reduction Study
Institute for Atherosclerosis Research, Russia1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2004年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- high-resolution B-mode ultrasonography of common carotid arteries
研究概览
简要总结
This study was designed to estimate the effect of two-year treatment with time-released garlic-based drug Allicor on the progression of carotid atherosclerosis in double-blinded placebo-controlled randomized clinical trial.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 40 Years 至 74 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Men aged 40 to 74 years
- •Subclinical carotid atherosclerosis detected by B-mode ultrasound (increased intima-media thickness 1100-2000 mcm)
- •Arterial normotension or mild arterial hypertension (systolic blood pressure <160 mm Hg, diastolic blood pressure <90 mm Hg)
- •Absence of chronic diseases demanding permanent drug administration (more than 2 month per year)
排除标准
- •Personal history or diagnostic of following diseases:
- •Transient ischemic attacks
- •Presence of chronic diseases demanding permanent drug administration (more than 2 month per year)
- •Condition of patients moderate to severe
- •Indications for surgical treatment of atherosclerotic lesions localized in the extracranial brachiocephalic system.
- •Individual intolerance of Allicor or appearance of side effects
研究组 & 干预措施
Allicor
Active Comparator
Allicor 150 mg tablet by mouth two times a day
干预措施: Allicor (Dietary Supplement)
Sugar pill
Placebo Comparator
Placebo tablet 150 mg by mouth two times a day
干预措施: Placebo (Drug)
结局指标
主要结局
high-resolution B-mode ultrasonography of common carotid arteries
时间窗: up to 2 years
Variation in carotid intima-media thickness (IMT) of the far wall of common carotid arteries
次要结局
- Measure of serum atherogenicity(up to 2 years)
研究者
研究点 (1)
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