Efficacy and Safety for Cimicifuga/Hypericum Product
CH
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
1 other identifier
interventional
210
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2011
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 25, 2011
CompletedFirst Posted
Study publicly available on registry
November 29, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedNovember 29, 2011
November 1, 2011
7 months
November 25, 2011
November 28, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Menopause Rating Scale
Climacteric Symptoms Evaluation - "MRS - Menopause Rating Scale\*
8 months
Secondary Outcomes (3)
Hamilton's Depression Scale
8 months
WHOQOL
8 months
Health Numbers
8 months (T-2 to T6)
Study Arms (3)
Cimicifuga+Hiperico
EXPERIMENTAL80 + 450 mg / tablet
Cimicifuga Herbarium
ACTIVE COMPARATOR80 mg / caps
Aplause®
ACTIVE COMPARATOR20 mg / tablet
Interventions
1 tablet, 80+450mg/tablet, twice a day for 1-3 months 1 tablet, 80+450mg/tablet, once a day for 3-6 months
2 caps, 80mg/caps, once a day for 1-3 months 1 caps, 80mg/caps, once a day for 3-6 months
4 tablets, 20mg/tablet, twice a day for 1-3 months 2 tablets, 20mg/tablet, twice a day for 3-6 months
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ISCMPA's Gynecology Ambulatory
Porto Alegre, Rio Grande do Sul, 90020-090, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Karla F Deud José, Pharm PhD
Phytopharm Consulting Brazil - karla@phytopharm.com.br
- PRINCIPAL INVESTIGATOR
Carla Vanin, MD MSc PhD
Federal University of Health Science of Porto Alegre
- PRINCIPAL INVESTIGATOR
Raquel P Dibi, MD MSc
Irmandade Santa Casa de Misericórdia de Porto Alegre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2011
First Posted
November 29, 2011
Study Start
November 1, 2011
Primary Completion
June 1, 2012
Study Completion
August 1, 2012
Last Updated
November 29, 2011
Record last verified: 2011-11