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Status unknownNCT01283568GHUpdated Nov 29, 2011

Safety and Efficacy Study of Gamaline+Hipericin in PMS

An observational study in Edema, Depression and Hot Flashes, sponsored by Phytopharm Consulting Brazil. Status unknown at 1 site in Brazil. Open to female participants aged 25 Years to 55 Years. Per ClinicalTrials.gov, last updated 2011-11-29.

Sponsored by Phytopharm Consulting Brazil · Observational

The sponsor has not verified this record recently (last verified Nov 2011), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
240
Ages
25 Years to 55 Years
Sex
Female
01

Study 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).

Read the 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

02

Conditions studied

  • Edema
  • Depression
  • Hot Flashes
  • Anxiety
  • Irritability

Keywords

  • PMS, climacteric, depression
03

In context

Hot Flashes

285 studies on the registry are indexed under Hot Flashes; 50 are open to participants now.

This study's planned enrollment of 240 is above the median of 88 across 17 observational studies indexed under Hot Flashes.

Browse Hot Flashes studies →

Lead sponsor

Phytopharm Consulting Brazil is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Only women from 25 to 55 years old with PMS symptoms

Inclusion criteria

  • climacteric pre-menopausal women between 45 e 55 anos
  • women between 25 e 44 anos

Exclusion criteria

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
240 participants (estimated)

Groups and cohorts

  • 1 - Gamaline+Hipericin - fertile women
  • 2- Gamaline+Hipericin - climateric women
  • 3- Gamaline- control - fertile women
  • 4 - Gamaline control - climateric women
06

Study locations

1 of 1 sites recruiting
  • Ambulatório de Ginecologia e Obstetrícia ISCMPA
    Porto Alegre, RS 90020-090, Brazil
    • Carla Vanin, MD MSc PhD · Contact · carlavanin@terra.com.br · +55 51 32148080
    • Raquel P Dibi, MD MSc · Sub investigator
    • Carla Vanin, MD MSc PhD · Principal investigator
    Recruiting
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT01283568
Lead sponsor
Phytopharm Consulting Brazil
Collaborators
Herbarium Laboratorio Botanico Ltda, Federal University of Health Science of Porto Alegre
Responsible party
Sponsor
First posted
Jan 26, 2011
Start date
Jan 2011
Primary completion
Dec 2011 (estimated)
Completion
Feb 2012 (estimated)
Last update
Nov 29, 2011

Study contacts

Carla Vanin, MD MSc PhD
Contact
carlavanin@terra.com.br
+55 51 99628061
Karla F Deud José, Pharm PhD
study chair · Phytopharm Consulting Brazil - karla@phytopharm.com.br

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.

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