Safety and Efficacy Study of Gamaline+Hipericin in PMS

Phase IV Study of Combined GAMALINE and HIPERICIN for Treating Pre-Menstrual Syndrome and Vasomotor Symptoms

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01283568

Acronym

Enrollment

240

Registered

2011-01-26

Start date

2011-01-31

Completion date

2012-02-29

Last updated

2011-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depression, Edema, Hot Flashes, Irritability

Keywords

PMS, climacteric, depression

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).

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

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

25 Years to 55 Years

Healthy volunteers

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

Countries

Brazil

Contacts

Primary ContactCarla Vanin, MD MSc PhD

carlavanin@terra.com.br+55 51 99628061

Outcome results