Vascular Effect of CIMICIFUGA RACEMOSA

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Vascular Effect of CIMICIFUGA RACEMOSA Versus Placebo Evaluated by Flow Mediated Dilatation of Brachial Artery (CRDILA)

Conditions
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Postmenopausal Symptoms

Intervention / Treatment
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* Drug: Cimifuga Racemosa
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Smoking Blood Pressure > 160/90 mm Hg. Breast and or endometrial cancer History of acute myocardial infarction Diabetes Vaginal bleeding of any origin Hepatic disease Thrombophlebitis or thromboembolic disorders

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>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 | Drug: Cimifuga Racemosa<br>* Experimental group will use 160mg of Cimifuga Racemosa for 28 days<br>* Other names: Acteia;|
| Placebo Comparator: Placebo<br>Women will use Placebo for 28 days and will be submitted to measurement of the diameter of the brachial artery before and after treatment | Drug: Placebo<br>* patients of the placebo group will use placebo once a day for 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of the brachial artery using flow-mediated dilation of post menopausal women, before and after use of Cimifuga Racemosa | 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. | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of symptoms and side effects | Patients symptoms before and after the use of Cimifuga Racemosa | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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postmenopause, vascular effects, CIMICIFUGA RACEMOSA