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

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ClinicalTrials.gov Identifier: NCT01283568
Recruitment Status : Unknown
Verified November 2011 by Phytopharm Consulting Brazil.
Recruitment status was:  Recruiting
First Posted : January 26, 2011
Last Update Posted : November 29, 2011
Sponsor:
Collaborators:
Herbarium Laboratorio Botanico Ltda
Federal University of Health Science of Porto Alegre
Information provided by (Responsible Party):
Phytopharm Consulting Brazil

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
Edema Depression Hot Flashes Anxiety Irritability

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
Estimated 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 : January 2011
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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




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

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

Responsible Party: Phytopharm Consulting Brazil
ClinicalTrials.gov Identifier: NCT01283568     History of Changes
Other Study ID Numbers: GAMALINEHIPERICIN
First Posted: January 26, 2011    Key Record Dates
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