- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03786809
Vascular Effect of CIMICIFUGA RACEMOSA (CRDILA)
August 13, 2019 updated by: Selmo Geber, Federal University of Minas Gerais
Vascular Effect of CIMICIFUGA RACEMOSA Versus Placebo Evaluated by Flow Mediated Dilatation of Brachial Artery (CRDILA)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minas Gerais
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Belo Horizonte, Minas Gerais, Brazil, 30130100
- Hospital das Clínicas - Universidade Federal de Minas Gerais
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
Experimental group will use 160mg of Cimifuga Racemosa for 28 days
Other Names:
|
Placebo Comparator: 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
|
patients of the placebo group will use placebo once a day for 28 days
|
What is the study measuring?
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
Time Frame: 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.
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency of symptoms and side effects
Time Frame: 28 days
|
Patients symptoms before and after the use of Cimifuga Racemosa
|
28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Selmo Geber, MD PhD, Universidde Federal de Minas Gerais
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2016
Primary Completion (Actual)
April 1, 2019
Study Completion (Actual)
May 1, 2019
Study Registration Dates
First Submitted
December 21, 2018
First Submitted That Met QC Criteria
December 24, 2018
First Posted (Actual)
December 26, 2018
Study Record Updates
Last Update Posted (Actual)
August 14, 2019
Last Update Submitted That Met QC Criteria
August 13, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- ETIC - CR-0417.0.203.000-09
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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