Safety and Efficacy Study of Gamaline+Hipericin in PMS (GH)
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ClinicalTrials.gov Identifier: NCT01283568
Verified November 2011 by Phytopharm Consulting Brazil. Recruitment status was: Recruiting
: January 26, 2011
Last Update Posted
: November 29, 2011
Phytopharm Consulting Brazil
Herbarium Laboratorio Botanico Ltda
Federal University of Health Science of Porto Alegre
GAMALINE is already register for PMS and HIPERICIN as antidepressive drug. Both plant extracts. The investigators will try the mixture and see if the vasomotor symptoms will disappear. The investigators expect that together all symptoms will be covered better than Gamaline alone. The investigators will run for 180 days measuring at T0, T1 and T6 (starting point, 30 days and 180 days).
Condition or disease
This protocol wants to show the advantages for the mixture GAMALINE 900mg+HIPERICIN 300mg - 2 herbal extracts for PMS treatment against the individual use of GAMALINE
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Ages Eligible for Study:
25 Years to 55 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Only women from 25 to 55 years old with PMS symptoms
climacteric pre-menopausal women between 45 e 55 anos
women between 25 e 44 anos
Age inferior 25 anos or superior 55 anos and/or decline invitation.
Under hormone therapy
Under psychiatric therapy or medication
History for allergies and hypersensitivity to one or both extracts