Safety and Efficacy Study of Gamaline+Hipericin in PMS

Depression Clinical Trial

— GH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01283568
• Other study ID #: GAMALINEHIPERICIN
• Status: Recruiting
• Phase: N/A
• First received: January 24, 2011
• Last updated: November 25, 2011
• Start date: January 2011
• Est. completion date: February 2012

Study information

• Verified date: November 2011
• Source: Phytopharm Consulting Brazil
• Contact: Carla Vanin, MD MSc PhD
• Phone: +55 51 99628061
• Email: carlavanin[@]terra.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in ResearchBrazil: National Health Surveillance Agency
• Study type: Observational

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: February 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 55 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anxiety
• Depression
• Edema
• Hot Flashes
• Irritability

Locations

Country	Name	City	State
Brazil	Ambulatório de Ginecologia e Obstetrícia ISCMPA	Porto Alegre	RS

Sponsors (3)

Lead Sponsor	Collaborator
Phytopharm Consulting Brazil	Federal University of Health Science of Porto Alegre, Herbarium Laboratorio Botanico Ltda

Country where clinical trial is conducted

Brazil,