NCT01741974已完成3 期
Double-blinded Placebo-controlled Multicenter Study of Anti-atherosclerotic and Estrogen-like Activity of Karinat in Perimenopausal Women
Institute for Atherosclerosis Research, Russia0 个研究点目标入组 340 人开始时间: 2005年10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
- 340
- 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 and anti-climacteric action of natural drug Karinat based on phytoestrogen-rich botanicals in perimenopausal 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
- 年龄范围
- 40 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Perimenopausal women aged 45 to 60 years with intact womb and ovaries
- •The absence of menstruations between 6 to 24 months
- •Last menstruation after the age of 40 years
- •Follicle-stimulating hormone (FSH) blood level ≥ 35 ng/ml
- •Mammography without nodal form of mastopathy or breast cancer signs
- •Absence of hypolipidemic therapy or HRT (hormone replacement therapy) during 6 months before the inclusion
排除标准
- •Administration of lipid-lowering drugs, and/or HRT, and/or phytoestrogens during 6 month before inclusion
- •Personal history or diagnostic of following diseases:
- •nodal form of mastopathy or breast cancer any cancer except non-melanoma skin cancer stroke or myocardial infarction chronic renal failure II-III chronic hepatic failure II-III liver cirrhosis chronic heart failure IIa-III exacerbation of chronic stomach or duodenal ulcer obesity (BMI >30 kg/m2) alcohol abuse uncontrolled arterial hypertension (systolic blood pressure > 160 mmHg, diastolic blood pressure > 90 mmHg) current cigarette smoking (>10 cigarettes a day) diabetes mellitus deep vein thrombosis or pulmonary embolism
- •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 tablet 500 mg 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 3 years
Variation of intima-media thickness of common carotid arteries
次要结局
- Measure of serum atherogenicity(up to 3 years)
研究者
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