Text Size

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

This study is currently recruiting participants.
Verified November 2011 by Phytopharm Consulting Brazil
Sponsor:
Collaborators:
Herbarium Laboratorio Botanico Ltda
Federal University of Health Science of Porto Alegre
Information provided by (Responsible Party):
Phytopharm Consulting Brazil
ClinicalTrials.gov Identifier:
NCT01283568
First received: January 24, 2011
Last updated: November 25, 2011
Last verified: November 2011
History of Changes
  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

Resource links provided by NLM:

U.S. FDA Resources

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

Ages Eligible for Study:   25 Years to 55 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Phytopharm Consulting Brazil
ClinicalTrials.gov Identifier: NCT01283568     History of Changes
Other Study ID Numbers: GAMALINEHIPERICIN
Study First Received: January 24, 2011
Last Updated: November 25, 2011
Health Authority: Brazil: National Committee of Ethics in Research
Brazil: National Health Surveillance Agency

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

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
Edema
Premenstrual Syndrome
Hot Flashes
 Mental Disorders
Behavioral Symptoms
Mood Disorders
Signs and Symptoms
Menstruation Disturbances
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013