Status:
UNKNOWN
Efficacy and Safety for Cimicifuga/Hypericum Product
Lead Sponsor:
Phytopharm Consulting Brazil
Collaborating Sponsors:
Herbarium Laboratorio Botanico Ltda
Complexo Hospitalar Santa Casa de Misericordia de Porto alegre
Conditions:
Perimenopausal Disorder
Eligibility:
FEMALE
45-60 years
Phase:
PHASE3
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 ...
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 Remif...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2012
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT01481025
Start Date
November 1 2011
End Date
August 1 2012
Last Update
November 29 2011
Active Locations (1)
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1
ISCMPA's Gynecology Ambulatory
Porto Alegre, Rio Grande do Sul, Brazil, 90020-090