Perimenopausal DisorderPhase 3CHNCT01481025
Efficacy and Safety for Cimicifuga/Hypericum Product
A Phase 3 study testing Cimicifuga + Hiperico, Cimicifuga Herbarium and Aplause® in people with Perimenopausal Disorder, run by Phytopharm Consulting Brazil at 1 site in Brazil.
Trial summary
Climacteric Complains bring to women many problems for living a normal life - hot flashes, irritation are 2 of many problems and the mixture of those 2 plant extract must bring a new horizon for this part of time. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women only
- Conditions the study is for
- Perimenopausal Disorder
- What is being tested?
- Cimicifuga + Hiperico, Cimicifuga Herbarium and Aplause®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2011to Aug 2012
- Phase
- Phase 3
- 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Climacteric women 45-60 years old - pre and postmenopausal
- Climacteric complains for at least 3 months
- No treatments for at least 2 months
- MRS score 0.4 or more for at least 3 items
- Hamilton's Scale score from 15-23
Who cannot join
- Hormon Therapy or any other for the last 3 months
- Antidepressive and Hypnotic medication for the last 3 months
- Sever illness (cardiac, hepatic, renal, digestive or metabolic) or TSH alteration
- History for allergies and hipersensitivity to any component of the drugs formulations
- No knowledge for reading or writing
- Suicide risk
Trial locations and contacts
1 site in 1 country.
Brazil1 site
ISCMPA's Gynecology Ambulatory
Porto Alegre, Rio Grande do Sul, 90020-090
Marli Chaves, Secretary, +55 51 81308454, contato@phytopharm.com.br
Gustavo Remus, Physical Edu, +55 51 9191-6535, remus@phytopharm.com.br
About this study
Official title: Phase 3 Study - Efficacy and Tolerance for the Mixture of Dry Extracts Black Cohosh and Saint John's Worth Versus Isolated Black Cohosh Extract for the Climacteric Symptoms' Control
Climacteric Complains bring to women many problems for living a normal life - hot flashes, irritation are 2 of many problems and the mixture of those 2 plant extract must bring a new horizon for this part of time.
Read the detailed description
2 herbal extracts used in general alone will be running together for the best climacteric women on quality of life.
The investigators will test the mixture already in the market as GynoPlus and RemifeminPlus, but as each extract has its own particularities the investigators will try CIM/HIP as a unique formulation versus Clifemin® as control and Aplause® as comparator.
This protocol was performed for the best of our volunteers.
- Conditions
- Perimenopausal Disorder
- Being tested
- Cimicifuga + Hiperico, Cimicifuga Herbarium, Aplause®
- Keywords
- Climacteric, Depression, Herbal treatment
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cimicifuga + HipericoDrug
1 tablet, 80+450mg/tablet, twice a day for 1-3 months
1 tablet, 80+450mg/tablet, once a day for 3-6 months
Cimicifuga HerbariumDrug
2 caps, 80mg/caps, once a day for 1-3 months
1 caps, 80mg/caps, once a day for 3-6 months
Aplause®Drug
4 tablets, 20mg/tablet, twice a day for 1-3 months 2 tablets, 20mg/tablet, twice a day for 3-6 months
| Study group | Role | What they receive |
|---|---|---|
| Cimicifuga+Hiperico | Experimental | 80 + 450 mg / tablet Receives: Drug: Cimicifuga + Hiperico |
| Cimicifuga Herbarium | Active comparator | 80 mg / caps Receives: Drug: Cimicifuga Herbarium |
| Aplause® | Active comparator | 20 mg / tablet Receives: Drug: Aplause® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Menopause Rating Scale
Climacteric Symptoms Evaluation - "MRS - Menopause Rating Scale*
Measured: 8 months
Secondary outcomes (3)
Hamilton's Depression Scale
Questionair for Depression Symptoms
Measured: 8 months
WHOQOL
Starting Point (T-2) and Ending Point (T6)
Measured: 8 months
Health Numbers
Starting Point (T0, T1, T3 and T6)
Measured: 8 months (T-2 to T6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionJun 2012 (estimated)
- Study completionAug 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perimenopausal DisorderStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phytopharm Consulting Brazil
- Sponsor type
- Research network
- Collaborators
- Herbarium Laboratorio Botanico Ltda, Complexo Hospitalar Santa Casa de Misericordia de Porto alegre
- Responsible party
- Sponsor
- Investigators
- Karla F Deud José, Pharm PhD, Study chair, Phytopharm Consulting Brazil - karla@phytopharm.com.brCarla Vanin, MD MSc PhD, Principal investigator, Federal University of Health Science of Porto AlegreRaquel P Dibi, MD MSc, Principal investigator, Irmandade Santa Casa de Misericórdia de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01481025
- Sponsor's protocol ID
- Cimicifuga/Herbarium
- Acronym
- CH
- Status last verified
- Nov 2011
- First submitted
- 25 Nov 2011
- Last updated
- 29 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study - Efficacy and Tolerance for the Mixture of Dry Extracts Black Cohosh and Saint John's Worth Versus Isolated Black Cohosh Extract for the Climacteric Symptoms' Control
- ClinicalTrials.gov ID
- NCT01481025
- Acronym / sponsor ID
- CH / Cimicifuga/Herbarium
- Conditions
- Perimenopausal Disorder
- Keywords
- Climacteric, Depression, Herbal treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Phytopharm Consulting BrazilResearch network
- Collaborators
- Herbarium Laboratorio Botanico Ltda, Complexo Hospitalar Santa Casa de Misericordia de Porto alegre
- Study start
- Nov 2011
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 29 Nov 2011 (estimated)
- 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.
Climacteric Complains bring to women many problems for living a normal life - hot flashes, irritation are 2 of many problems and the mixture of those 2 plant extract must bring a new horizon for this part of time.
Detailed description
2 herbal extracts used in general alone will be running together for the best climacteric women on quality of life.
The investigators will test the mixture already in the market as GynoPlus and RemifeminPlus, but as each extract has its own particularities the investigators will try CIM/HIP as a unique formulation versus Clifemin® as control and Aplause® as comparator.
This protocol was performed for the best of our volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cimicifuga+Hiperico | Experimental | Drug: Cimicifuga + Hiperico80 + 450 mg / tablet |
| Cimicifuga Herbarium | Active comparator | Drug: Cimicifuga Herbarium80 mg / caps |
| Aplause® | Active comparator | Drug: Aplause®20 mg / tablet |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Climacteric women 45-60 years old - pre and postmenopausal
- Climacteric complains for at least 3 months
- No treatments for at least 2 months
- MRS score 0.4 or more for at least 3 items
- Hamilton's Scale score from 15-23
Key exclusion criteria (6 listed)
- Hormon Therapy or any other for the last 3 months
- Antidepressive and Hypnotic medication for the last 3 months
- Sever illness (cardiac, hepatic, renal, digestive or metabolic) or TSH alteration
- History for allergies and hipersensitivity to any component of the drugs formulations
- No knowledge for reading or writing
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 |
|---|---|---|
| Cimicifuga + Hiperico1 tablet, 80+450mg/tablet, twice a day for 1-3 months 1 tablet, 80+450mg/tablet, once a day for 3-6 months | Drug | Cimicifuga+Hiperico |
| Cimicifuga Herbarium2 caps, 80mg/caps, once a day for 1-3 months 1 caps, 80mg/caps, once a day for 3-6 months | Drug | Cimicifuga Herbarium |
| Aplause®4 tablets, 20mg/tablet, twice a day for 1-3 months 2 tablets, 20mg/tablet, twice a day for 3-6 months | Drug | Aplause® |
Primary outcome
Menopause Rating Scale
Time frame: 8 months
Climacteric Symptoms Evaluation - "MRS - Menopause Rating Scale*
3 secondary outcomes
Hamilton's Depression Scale
Time frame: 8 months
WHOQOL
Time frame: 8 months
Health Numbers
Time frame: 8 months (T-2 to T6)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2011.
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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.
Karla F Deud José, Pharm PhD study chair
Phytopharm Consulting Brazil - karla@phytopharm.com.br
Carla Vanin, MD MSc PhD principal investigator
Federal University of Health Science of Porto Alegre
Raquel P Dibi, MD MSc principal investigator
Irmandade Santa Casa de Misericórdia de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cimicifuga + Hiperico, Cimicifuga Herbarium and Aplause® in people with Perimenopausal Disorder, run by Phytopharm Consulting Brazil 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 29 Nov 2011. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marli Chaves, Secretary (+55 51 8130-8454, contato@phytopharm.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menopause Rating Scale (time frame: 8 months). 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 29 Nov 2011; AzTrials last refreshed its copy on 31 Oct 2026.