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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2011 by Phytopharm Consulting Brazil.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01283568
First Posted: January 26, 2011
Last Update Posted: November 29, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Herbarium Laboratorio Botanico Ltda
Federal University of Health Science of Porto Alegre
Information provided by (Responsible Party):
Phytopharm Consulting Brazil
  Purpose
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
Edema Depression Hot Flashes Anxiety Irritability

Study Type: Observational
Study Design: 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

Further study details as provided by Phytopharm Consulting Brazil:

Estimated Enrollment: 240
Study Start Date: January 2011
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1 - Gamaline+Hipericin - fertile women
2- Gamaline+Hipericin - climateric women
3- Gamaline- control - fertile women
4 - Gamaline control - climateric women

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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Only women from 25 to 55 years old with PMS symptoms
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01283568


Contacts
Contact: Carla Vanin, MD MSc PhD +55 51 99628061 carlavanin@terra.com.br

Locations
Brazil
Ambulatório de Ginecologia e Obstetrícia ISCMPA Recruiting
Porto Alegre, RS, Brazil, 90020-090
Contact: Carla Vanin, MD MSc PhD    +55 51 32148080    carlavanin@terra.com.br   
Sub-Investigator: Raquel P Dibi, MD MSc         
Principal Investigator: Carla Vanin, MD MSc PhD         
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
  More Information

Responsible Party: Phytopharm Consulting Brazil
ClinicalTrials.gov Identifier: NCT01283568     History of Changes
Other Study ID Numbers: GAMALINEHIPERICIN
First Submitted: January 24, 2011
First Posted: January 26, 2011
Last Update Posted: November 29, 2011
Last Verified: November 2011

Keywords provided by Phytopharm Consulting Brazil:
PMS, climacteric, depression

Additional relevant MeSH terms:
Depression
Hot Flashes
Behavioral Symptoms
Signs and Symptoms