NCT01283568

Safety and Efficacy Study of Gamaline+Hipericin in PMS

Phase IV Study of Combined GAMALINE and HIPERICIN for Treating Pre-Menstrual Syndrome and Vasomotor Symptoms

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 240 (estimated)
• Sponsor: Phytopharm Consulting Brazil · Network
• Sex: Female
• Age: 25 Years – 55 Years
• Healthy volunteers: Not accepted

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

Conditions

• Edema
• Depression
• Hot Flashes
• Anxiety
• Irritability

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-12-01
• Completion: 2012-02-01
• First posted: 2011-01-26
• Last updated: 2011-11-29

Locations

1 site across 1 country: Brazil