Safety and Efficacy Study of Gamaline+Hipericin in PMS (GH)

November 25, 2011 updated by: Phytopharm Consulting Brazil

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

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).

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90020-090
        • Recruiting
        • Ambulatório de Ginecologia e Obstetrícia ISCMPA
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Only women from 25 to 55 years old with PMS symptoms

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1 - Gamaline+Hipericin - fertile women
2- Gamaline+Hipericin - climateric women
3- Gamaline- control - fertile women
4 - Gamaline control - climateric women

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Phytopharm Consulting Brazil

Collaborators

Federal University of Health Science of Porto Alegre
Herbarium Laboratorio Botanico Ltda

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

December 1, 2011

Study Completion (Anticipated)

February 1, 2012

Study Registration Dates

First Submitted

January 24, 2011

First Submitted That Met QC Criteria

January 25, 2011

First Posted (Estimate)

January 26, 2011

Study Record Updates

Last Update Posted (Estimate)

November 29, 2011

Last Update Submitted That Met QC Criteria

November 25, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GAMALINEHIPERICIN

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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