Safety and Efficacy Study of Gamaline+Hipericin in PMS

Last updated: November 25, 2011
Sponsor: Phytopharm Consulting Brazil
Overall Status: Trial Status Unknown

Phase

N/A

Condition

Depression

Manic Disorders

Anger

Treatment

N/A

Clinical Study ID

NCT01283568
GAMALINEHIPERICIN
  • Ages 25-55
  • Female

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • climacteric pre-menopausal women between 45 e 55 anos

  • women between 25 e 44 anos

Exclusion

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

Total Participants: 240
Study Start date:
January 01, 2011
Estimated Completion Date:
February 29, 2012

Study 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

Connect with a study center

  • Ambulatório de Ginecologia e Obstetrícia ISCMPA

    Porto Alegre, RS 90020-090
    Brazil

    Active - Recruiting

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