Vascular Effect of CIMICIFUGA RACEMOSA Versus Placebo Evaluated by Flow Mediated Dilatation of Brachial Artery (CRDILA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Measurement of the brachial artery using flow-mediated dilation of post menopausal women, before and after use of Cimifuga Racemosa
研究概览
简要总结
Postmenopausal women with vascular symptoms will use Cimifuga Racemosa or Placebo and the effects will be evaluated using Flow-Mediated Dilatation of the brachial artery.
详细描述
The interruption of the secretion of ovarian steroids after menopause, determines a change in the vascular pattern in several levels. Thus, several vascular effects might interfere with women's health. The use of hormone replacement therapy has contributed to the improvement in these effects. In previous studies, the investigators observed the effects of hormonal replacement therapy in improving such effects in postmenopausal women. The aim of the present study is to evaluate the effects of CIMICIFUGA RACEMOSA on the Flow-Mediated Dilatation of the brachial artery.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with postmenopausal vascular symptoms
- •Women without menstrual cycles within the last 12 months and follicle stimulating hormone (FSH) > 30 International Units(IU)/Litre
- •Women that were not using drugs with potential vascular effect within the last 1 year
- •Women that were not using hormone replacement therapy within the last 1 year
排除标准
- •Blood Pressure > 160/90 mm Hg.
- •Breast and or endometrial cancer
- •History of acute myocardial infarction
- •Vaginal bleeding of any origin
- •Hepatic disease
- •Thrombophlebitis or thromboembolic disorders
研究组 & 干预措施
Experimental
Women will use Cimifuga Racemosa for 28 days and will be submitted to measurement of the diameter of the brachial artery before and after treatment
干预措施: Cimifuga Racemosa (Drug)
Placebo
Women will use Placebo for 28 days and will be submitted to measurement of the diameter of the brachial artery before and after treatment
干预措施: Placebo (Drug)
结局指标
主要结局
Measurement of the brachial artery using flow-mediated dilation of post menopausal women, before and after use of Cimifuga Racemosa
时间窗: 28 days
We will evaluate the vascular effect of Cimifuga Racemosa on the brachial artery. The diameter of the artery will be measured before and one month after use of Cimifuga Racemosa and, in both situations, before and after the use of a cuff in the forearm. Measurement will be in millimeters.
次要结局
- Frequency of symptoms and side effects(28 days)
研究者
Selmo Geber
Professor
Federal University of Minas Gerais