Clincosm LogoSign in Get a demo

GH: Safety and Efficacy Study of Gamaline+Hipericin in PMS

Sponsor
Phytopharm Consulting Brazil (Other)
Overall Status
Unknown status
CT.gov ID
NCT01283568
Collaborator
Herbarium Laboratorio Botanico Ltda (Industry), Federal University of Health Science of Porto Alegre (Other)
240
Enrollment
1
Location
13
Duration (Months)
18.4
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    240 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Phase IV Study of Combined GAMALINE and HIPERICIN for Treating Pre-Menstrual Syndrome and Vasomotor Symptoms
    Study Start Date :
    Jan 1, 2011
    Anticipated Primary Completion Date :
    Dec 1, 2011
    Anticipated Study Completion Date :
    Feb 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    1 - Gamaline+Hipericin - fertile women
    2- Gamaline+Hipericin - climateric women
    3- Gamaline- control - fertile women
    4 - Gamaline control - climateric women

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      25 Years to 55 Years
      Sexes Eligible for Study:
      Female
      Accepts Healthy Volunteers:
      No
      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

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Ambulatório de Ginecologia e Obstetrícia ISCMPA Porto Alegre RS Brazil 90020-090

      Sponsors and Collaborators

      • Phytopharm Consulting Brazil
      • Herbarium Laboratorio Botanico Ltda
      • Federal University of Health Science of Porto Alegre

      Investigators

      • Study Chair: Karla F Deud José, Pharm PhD, Phytopharm Consulting Brazil - karla@phytopharm.com.br

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Phytopharm Consulting Brazil
      ClinicalTrials.gov Identifier:
      NCT01283568
      Other Study ID Numbers:
      • GAMALINEHIPERICIN
      First Posted:
      Jan 26, 2011
      Last Update Posted:
      Nov 29, 2011
      Last Verified:
      Nov 1, 2011
      Keywords provided by Phytopharm Consulting Brazil
      PMS, climacteric, depression
      Additional relevant MeSH terms:
      Hot Flashes
      Depression

      Study Results

      No Results Posted as of Nov 29, 2011