Safety and Efficacy Study of Gamaline+Hipericin in PMS
NCT01283568 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 240
Last updated 2011-11-29
Summary
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).
Conditions
- Edema
- Depression
- Hot Flashes
- Anxiety
- Irritability
Sponsors & Collaborators
-
Herbarium Laboratorio Botanico Ltda
collaborator INDUSTRY -
Federal University of Health Science of Porto Alegre
collaborator OTHER -
Phytopharm Consulting Brazil
lead NETWORK
Principal Investigators
-
Karla F Deud José, Pharm PhD · Phytopharm Consulting Brazil - [email protected]
Eligibility
- Min Age
- 25 Years
- Max Age
- 55 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-01-31
- Primary Completion
- 2011-12-31
- Completion
- 2012-02-29
Countries
- Brazil
Study Locations
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