Postmenopausal SymptomsCRDILANCT03786809
Vascular Effect of CIMICIFUGA RACEMOSA
A study testing Cimifuga Racemosa in people with Postmenopausal Symptoms, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Postmenopausal Symptoms
- What is being tested?
- Cimifuga Racemosa
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2016to May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clinicas - Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, 30130100
About this study
Official title: 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.
Read the 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.
- Conditions
- Postmenopausal Symptoms
- Being tested
- Cimifuga Racemosa, Placebo
- Keywords
- postmenopause, vascular effects, CIMICIFUGA RACEMOSA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cimifuga RacemosaDrug
Also called Clifemin, Acteia
Experimental group will use 160mg of Cimifuga Racemosa for 28 days
PlaceboDrug
patients of the placebo group will use placebo once a day for 28 days
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Cimifuga Racemosa |
| Placebo | Placebo comparator | Women will use Placebo for 28 days and will be submitted to measurement of the diameter of the brachial artery before and after treatment Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Secondary outcomes (1)
Frequency of symptoms and side effects
Patients symptoms before and after the use of Cimifuga Racemosa
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study startJun 2016
- Primary completionApr 2019
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Selmo Geber, Federal University of Minas Gerais
- Investigators
- Selmo Geber, MD PhD, Principal investigator, Universidde Federal de Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03786809
- Sponsor's protocol ID
- ETIC - CR-0417.0.203.000-09
- Acronym
- CRDILA
- Status last verified
- Aug 2019
- First submitted
- 21 Dec 2018
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Effect of CIMICIFUGA RACEMOSA Versus Placebo Evaluated by Flow Mediated Dilatation of Brachial Artery (CRDILA)
- ClinicalTrials.gov ID
- NCT03786809
- Acronym / sponsor ID
- CRDILA / ETIC - CR-0417.0.203.000-09
- Conditions
- Postmenopausal Symptoms
- Keywords
- postmenopause, vascular effects, CIMICIFUGA RACEMOSA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 26 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Cimifuga RacemosaWomen will use Cimifuga Racemosa for 28 days and will be submitted to measurement of the diameter of the brachial artery before and after treatment |
| Placebo | Placebo comparator | Drug: PlaceboWomen will use Placebo for 28 days and will be submitted to measurement of the diameter of the brachial artery before and after treatment |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Smoking
- Blood Pressure > 160/90 mm Hg.
- Breast and or endometrial cancer
- History of acute myocardial infarction
- Diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cimifuga RacemosaAlso: Clifemin, ActeiaExperimental group will use 160mg of Cimifuga Racemosa for 28 days | Drug | Experimental |
| Placebopatients of the placebo group will use placebo once a day for 28 days | Drug | Placebo |
Primary outcome
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.
1 secondary outcome
Frequency of symptoms and side effects
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Selmo Geber, MD PhD principal investigator
Universidde Federal de Minas Gerais
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cimifuga Racemosa in people with Postmenopausal Symptoms, run by Federal University of Minas Gerais at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of the brachial artery using flow-mediated dilation of post menopausal women, before and after use of Cimifuga Racemosa (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2019.