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Safety and Efficacy Study of Gamaline+Hipericin in PMS

NCT ID: NCT01283568

Last Updated: 2011-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-02-29

Brief Summary

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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

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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

Conditions

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Edema Depression Hot Flashes Anxiety Irritability

Keywords

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PMS, climacteric, depression

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1 - Gamaline+Hipericin - fertile women

No interventions assigned to this group

2- Gamaline+Hipericin - climateric women

No interventions assigned to this group

3- Gamaline- control - fertile women

No interventions assigned to this group

4 - Gamaline control - climateric women

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Herbarium Laboratorio Botanico Ltda

INDUSTRY

Sponsor Role collaborator

Federal University of Health Science of Porto Alegre

OTHER

Sponsor Role collaborator

Phytopharm Consulting Brazil

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karla F Deud José, Pharm PhD

Role: STUDY_CHAIR

Phytopharm Consulting Brazil - [email protected]

Locations

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Ambulatório de Ginecologia e Obstetrícia ISCMPA

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Carla Vanin, MD MSc PhD

Role: CONTACT

Phone: +55 51 99628061

Email: [email protected]

Facility Contacts

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Carla Vanin, MD MSc PhD

Role: primary

Other Identifiers

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GAMALINEHIPERICIN

Identifier Type: -

Identifier Source: org_study_id