Safety and Efficacy Study of Gamaline+Hipericin in PMS

• Conditions: Edema; Depression; Hot Flashes; Anxiety; Irritability

• Registration Number: NCT01283568
• Lead Sponsor: Phytopharm Consulting Brazil

Brief 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).

Detailed Description

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

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-24
• Study First Submitted QC: 2011-01-25
• Study First Posted: 2011-01-26
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-25
• Last Update Posted: 2011-11-29
• Primary Completion: 2011-12
• Study Completion: 2012-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 240

Inclusion Criteria

• climacteric pre-menopausal women between 45 e 55 anos
• women between 25 e 44 anos

Exclusion Criteria

• Age inferior 25 anos or superior 55 anos and/or decline invitation.
• Patients pos-menopause
• Under hormone therapy
• Thyroid disease
• Under psychiatric therapy or medication
• History for allergies and hypersensitivity to one or both extracts
• Breast feeding or pregnancy
• No knowledge for writing and/or reading

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Ambulatório de Ginecologia e Obstetrícia ISCMPA; 🇧🇷 Porto Alegre, RS, Brazil