Safety and Efficacy Study of Gamaline+Hipericin in PMS | NCT01283568

Studies
Safety and Efficacy Study of Gamaline+Hipericin in PMS

NCT01283568

Sponsor

Phytopharm Consulting Brazil

Status

Unknown status

Last Update Posted

Nov 29, 2011Estimated

Enrollment

240Estimated

Phase

Not provided

Conditions

Edema
Depression
Hot Flashes
Anxiety
Irritability

Interventions

Not provided

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Dec 2011Estimated

Completion Date

Feb 2012Estimated

First Submitted Date

Jan 24, 2011

First Submission Date that Met QC Criteria

Jan 25, 2011

First Posted Date

Jan 26, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 25, 2011

Last Update Posted Date

Nov 29, 2011Estimated

Name	Class
Herbarium Laboratorio Botanico Ltda	INDUSTRY
Federal University of Health Science of Porto Alegre	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

240Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1 - Gamaline+Hipericin - fertile women
2- Gamaline+Hipericin - climateric women
3- Gamaline- control - fertile women
4 - Gamaline control - climateric women

Interventions

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Only women from 25 to 55 years old with PMS symptoms

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Carla Vanin, MD MSc PhD	Contact	+55 51 99628061		carlavanin@terra.com.br

Overall Officials

Name	Affiliation	Role
Karla F Deud José, Pharm PhD	Phytopharm Consulting Brazil - karla@phytopharm.com.br	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ambulatório de Ginecologia e Obstetrícia ISCMPA	Recruiting	Porto Alegre	Rio Grande do Sul	90020-090	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D004487	Edema
D003863	Depression
D019584	Hot Flashes
D001008	Anxiety Disorders

Ancestor Terms

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D001526	Behavioral Symptoms
D001519	Behavior

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Browse Branches

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