NCT01742000已完成3 期
Double-blinded Placebo-controlled Study of Anti-atherosclerotic Activity of Karinat in Postmenopausal Women
Institute for Atherosclerosis Research, Russia0 个研究点目标入组 180 人开始时间: 2007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
- 180
- 主要终点
- B-mode ultrasound of carotid arteries
研究概览
简要总结
The purpose of this study is to investigate the anti-atherosclerotic action of natural drug Karinat based on phytoestrogen-rich botanicals in postmenopausal women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women at least 5 years after menopause
- •Maximum intima-media thickness of common carotid artery more than 0,80 mm (ultrasonographic B-mode examination)
- •The absence of climacteric syndrome (less than 3 points by Blatt-Kupperman scale)
- •The absence of chronic diseases demanding permanent drug administration (more than 2 month per year)
- •The absence of hypolipidemic therapy or hormone replacement therapy during 6 months before the inclusion
排除标准
- •Administration of lipid-lowering drugs, and/or hormone replacement therapy, and/or phytoestrogens during 6 month before inclusion
- •Continuous administration of sulfonylurea derivatives, and/or beta-blockers, and/or calcium antagonists (more than 2 months per year)
- •Personal history or diagnostic of following diseases:
- •Personal history of stroke, coronary heart disease, acute myocardial infarction or transient ischemic attacks
- •Pulmonary thromboembolism
- •Chronic heart failure IIa-III
- •Uncontrolled arterial hypertension (systolic blood pressure > 145 mmHg, diastolic blood pressure > 95 mmHg under hypotensive therapy)
- •Chronic renal failure II-III
- •Chronic hepatic failure II-III
- •Liver cirrhosis
- •Individual intolerance of Karinat or major side effects
研究组 & 干预措施
Karinat
Active Comparator
Karinat 500 mg tablet by mouth three times a day
干预措施: Karinat (Dietary Supplement)
Sugar pill
Placebo Comparator
Placebo 500 mg tablet by mouth three times a day
干预措施: Placebo (Drug)
结局指标
主要结局
B-mode ultrasound of carotid arteries
时间窗: up to 2 years
Variation of intima-media thickness of common carotid arteries
次要结局
- Measure of serum atherogenicity(up to 2 years)
研究者
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