Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
210 participants
INTERVENTIONAL
2011-11-30
2012-08-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Cimicifuga+Hiperico
80 + 450 mg / tablet
Cimicifuga + Hiperico
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 Herbarium
80 mg / caps
Cimicifuga Herbarium
2 caps, 80mg/caps, once a day for 1-3 months
1 caps, 80mg/caps, once a day for 3-6 months
Aplause®
20 mg / tablet
Aplause®
4 tablets, 20mg/tablet, twice a day for 1-3 months 2 tablets, 20mg/tablet, twice a day for 3-6 months
Interventions
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Cimicifuga + Hiperico
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 Herbarium
2 caps, 80mg/caps, once a day for 1-3 months
1 caps, 80mg/caps, once a day for 3-6 months
Aplause®
4 tablets, 20mg/tablet, twice a day for 1-3 months 2 tablets, 20mg/tablet, twice a day for 3-6 months
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
45 Years
60 Years
FEMALE
No
Sponsors
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Herbarium Laboratorio Botanico Ltda
INDUSTRY
Complexo Hospitalar Santa Casa de Misericordia de Porto alegre
UNKNOWN
Phytopharm Consulting Brazil
NETWORK
Responsible Party
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Principal Investigators
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Carla Vanin, MD MSc PhD
Role: PRINCIPAL_INVESTIGATOR
Federal University of Health Science of Porto Alegre
Raquel P Dibi, MD MSc
Role: PRINCIPAL_INVESTIGATOR
Irmandade Santa Casa de Misericórdia de Porto Alegre
Locations
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ISCMPA's Gynecology Ambulatory
Porto Alegre, Rio Grande do Sul, Brazil
Countries
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Central Contacts
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Facility Contacts
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Marli Chaves, Secretary
Role: primary
Gustavo Remus, Physical Edu
Role: backup
Other Identifiers
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Cimicifuga/Herbarium
Identifier Type: -
Identifier Source: org_study_id