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GAMALINE®+HIPERICIN® for PMS Treatment and Vasomotor Symptoms

NCT ID: NCT01365676

Last Updated: 2011-12-06

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

Clinical Phase

PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Premenstrual Syndrome Uterus; Hemorrhage, Preclimacteric or Premenopausal

Keywords

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Edema Depression Hot Flashes Anxiety Irritability PMS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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GAMALINE® + HIPERICIN® 25-44 years old

Fertile women 24-44 years old with PMS symptoms

Group Type EXPERIMENTAL

GAMALINE® + HIPERICIN®

Intervention Type DRUG

GAMALINE® 900mg + HIPERICIN 300mg T0 = 2 soft caps of each / day (1st month) T1-T6 = 1 soft caps of each / day (2nd - 6th month)

GAMALINE® 25-44 years old

Fertile women 24-44 years old with PMS symptoms

Group Type ACTIVE_COMPARATOR

GAMALINE®

Intervention Type DRUG

GAMALINE® 900mg T0= 2 soft caps / day (1st month) T1-T6 = 1 soft caps / day (2nd - 6th month)

GAMALINE® + HIPERICIN® 45-55 years old

Climacteric women with PMS symptoms

Group Type EXPERIMENTAL

GAMALINE® + HIPERICIN®

Intervention Type DRUG

GAMALINE® 900mg + HIPERICIN 300mg T0 = 2 soft caps of each / day (1st month) T1-T6 = 1 soft caps of each / day (2nd - 6th month)

GAMALINE® 45-55 years old

Climacteric women with PMS symptoms

Group Type ACTIVE_COMPARATOR

GAMALINE®

Intervention Type DRUG

GAMALINE® 900mg T0= 2 soft caps / day (1st month) T1-T6 = 1 soft caps / day (2nd - 6th month)

Interventions

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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)

Intervention Type DRUG

GAMALINE®

GAMALINE® 900mg T0= 2 soft caps / day (1st month) T1-T6 = 1 soft caps / day (2nd - 6th month)

Intervention Type DRUG

Other Intervention Names

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GAMALINE® BATCH 8663A0 MS 1.1860.0061.002-9 HIPERICIN® BATCH 867911 MS 1.1860.0003.003-0 GAMALINE® BATCH 8663A0 MS 1.1860.0061.002-9

Eligibility Criteria

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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
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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Carla Vanin, MD MSc PhD

Role: PRINCIPAL_INVESTIGATOR

UFCSPA-Universidade Federal de Ciências da Saúde de Porto Alegre

Karla F Deud José, PharmD PhD

Role: STUDY_CHAIR

Phytopharm Consulting Brazil

Locations

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Ambulatório de Ginecologia e Obstetrícia ISCMPA

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

Central Contacts

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Marli Chaves, Secretary

Role: CONTACT

Phone: +55 51 8130-8454

Email: [email protected]

Gustavo Remus, Physical Education

Role: CONTACT

Phone: +55 51 9191-6535

Email: [email protected]

Facility Contacts

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Marli Chaves

Role: primary

Karla F Deud José, PharmD PhD

Role: backup

Other Identifiers

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GAM+HIP

Identifier Type: -

Identifier Source: org_study_id