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GAMALINE®+HIPERICIN® for PMS Treatment and Vasomotor Symptoms (657/10UFCSPA)

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 December 2011 by Phytopharm Consulting Brazil.
Recruitment status was:  Not yet recruiting
Sponsor:
Collaborators:
Herbarium Laboratório Botânico Ltda
Federal University of Health Science of Porto Alegre
Information provided by (Responsible Party):
Phytopharm Consulting Brazil
ClinicalTrials.gov Identifier:
NCT01365676
First received: May 26, 2011
Last updated: December 5, 2011
Last verified: December 2011
May 26, 2011
December 5, 2011
March 2012
October 2012   (Final data collection date for primary outcome measure)
  • PMS calendar [ Time Frame: 240 days ]
    Evaluation will run daily during the 240 days, comparing the results before treatment [60 days (T-2) and 30 days (T-1)]. Starting point (T0) treatment/under prescription, till 180 days treatment (T6).
  • LAB Tests [ Time Frame: T0 T1 and T6 ]
    Blood sample tests before T0 (all arms), after T1 (30 days only for experimental group) and end of T6 (after 180 days of prescription for all arms)
  • PMS calendar [ Time Frame: 240 days ]
    Evaluation will run daily during the 240 days, comparing the results for the traetment. T-2 (60 days before) T-1 (30 days before), T0 (starting point) till T6 (180 days treatment).
  • LAB Tests [ Time Frame: T0 T1 and T6 ]
    Blood sample tests before T0 (all arms), after T1 (30 days only for experimental group) and end of T6 (after 180 days of prescription for all arms)
Complete list of historical versions of study NCT01365676 on ClinicalTrials.gov Archive Site
WHOQOL [ Time Frame: 06 months ]
WHOQOL will be evaluated at T-2 and T6 where T-2 is at the first interview after inclusion and T6 is at the end point of treatment.
WHOQOL [ Time Frame: 06 months ]
WHOQOL will be evaluated at T-2 and T6 where T-2 is at the first interview for inclusion and T6 is at the end point of treatment.
Not Provided
Not Provided
 
GAMALINE®+HIPERICIN® for PMS Treatment and Vasomotor Symptoms
Phase 3 Study Efficacy and Tolerance: The Use of 2 Phytomedicines in Association GAMALINE® 900mg + HIPERICIN® 300mg for the Treatment of Pre-Menstrual Syndrome (PMS) and Vasomotor Symptoms
2 phytomedicines already in the market: GAMALINE® for premenstrual syndrome and HIPERICIN® as antidepressant will be prescribed together for treating women with Premenstrual Syndrome (PMS) symptoms and vasomotor problems for checking the advantage compared to the GAMALINE® prescription alone.
Test with 2 female groups: 25-44 years old (reproductive age) and 45-55 years old (climacteric premenopausal age) complaining about all symptoms related with premenstrual syndrome.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
  • Premenstrual Syndrome
  • Uterus; Hemorrhage, Preclimacteric or Premenopausal
  • Drug: GAMALINE® + HIPERICIN®
    GAMALINE® 900mg + HIPERICIN 300mg T0 = 2 soft caps of each / day (1st month) T1-T6 = 1 soft caps of each / day (2nd - 6th month)
    Other Names:
    • GAMALINE® BATCH 8663A0 MS 1.1860.0061.002-9
    • HIPERICIN® BATCH 867911 MS 1.1860.0003.003-0
  • Drug: GAMALINE®
    GAMALINE® 900mg T0= 2 soft caps / day (1st month) T1-T6 = 1 soft caps / day (2nd - 6th month)
    Other Name: GAMALINE® BATCH 8663A0 MS 1.1860.0061.002-9
  • Experimental: GAMALINE® + HIPERICIN® 25-44 years old
    Fertile women 24-44 years old with PMS symptoms
    Intervention: Drug: GAMALINE® + HIPERICIN®
  • Active Comparator: GAMALINE® 25-44 years old
    Fertile women 24-44 years old with PMS symptoms
    Intervention: Drug: GAMALINE®
  • Experimental: GAMALINE® + HIPERICIN® 45-55 years old
    Climacteric women with PMS symptoms
    Intervention: Drug: GAMALINE® + HIPERICIN®
  • Active Comparator: GAMALINE® 45-55 years old
    Climacteric women with PMS symptoms
    Intervention: Drug: GAMALINE®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
240
December 2012
October 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • fertile women between 25-44 years old
  • climacteric women between 45-55 years old

Exclusion Criteria:

  • inferior age to 25 years old
  • superior age to 55 years old
  • post-menopausal
  • under hormone therapy
  • thyroid disease
  • under psychiatric therapy or medication
  • history for allergies and/or hypersensitivity to any component
  • breast feeding or pregnancy
  • no knowledge for writing and/or reading
Sexes Eligible for Study: Female
25 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT01365676
GAM+HIP
Yes
Not Provided
Not Provided
Phytopharm Consulting Brazil
Phytopharm Consulting Brazil
  • Herbarium Laboratório Botânico Ltda
  • Federal University of Health Science of Porto Alegre
Principal Investigator: Carla Vanin, MD MSc PhD UFCSPA-Universidade Federal de Ciências da Saúde de Porto Alegre
Study Chair: Karla F Deud José, PharmD PhD Phytopharm Consulting Brazil
Phytopharm Consulting Brazil
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP