EdemaGHNCT01283568
Safety and Efficacy Study of Gamaline+Hipericin in PMS
An observational study of Edema and Depression, run by Phytopharm Consulting Brazil at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 55 years, women only
- Conditions the study is for
- Edema, Depression, Hot Flashes
- How many people
- 240 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2011to Feb 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- Women only
- No healthy volunteers
- Adult
Study population: Only women from 25 to 55 years old with PMS symptoms
Who may be able to join
- climacteric pre-menopausal women between 45 e 55 anos
- women between 25 e 44 anos
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Ambulatório de Ginecologia e Obstetrícia ISCMPA
Porto Alegre, Rio Grande do Sul, 90020-090
Carla Vanin, MD MSc PhD, +55 51 32148080, carlavanin@terra.com.br
Raquel P Dibi, MD MSc
About this study
Official title: Phase IV Study of Combined GAMALINE and HIPERICIN for Treating Pre-Menstrual Syndrome and Vasomotor Symptoms
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
- Conditions
- Edema, Depression, Hot Flashes, Anxiety, Irritability
- Keywords
- PMS, climacteric, depression
- Medical subject headings
- Edema, Depression, Hot Flashes, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 - Gamaline+Hipericin - fertile women | Not described | |
| 2- Gamaline+Hipericin - climateric women | Not described | |
| 3- Gamaline- control - fertile women | Not described | |
| 4 - Gamaline control - climateric women | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2011 (estimated)
- Study completionFeb 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phytopharm Consulting Brazil
- Sponsor type
- Research network
- Collaborators
- Herbarium Laboratorio Botanico Ltda, Federal University of Health Science of Porto Alegre
- Responsible party
- Sponsor
- Investigators
- Karla F Deud José, Pharm PhD, Study chair, Phytopharm Consulting Brazil - karla@phytopharm.com.br
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01283568
- Sponsor's protocol ID
- GAMALINEHIPERICIN
- Acronym
- GH
- Status last verified
- Nov 2011
- First submitted
- 24 Jan 2011
- Last updated
- 29 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study of Combined GAMALINE and HIPERICIN for Treating Pre-Menstrual Syndrome and Vasomotor Symptoms
- ClinicalTrials.gov ID
- NCT01283568
- Acronym / sponsor ID
- GH / GAMALINEHIPERICIN
- Conditions
- Edema, Depression, Hot Flashes, Anxiety, Irritability
- Keywords
- PMS, climacteric, depression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Phytopharm Consulting BrazilResearch network
- Collaborators
- Herbarium Laboratorio Botanico Ltda, Federal University of Health Science of Porto Alegre
- Study start
- Jan 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Feb 2012 (estimated)
- First posted
- 26 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 - Gamaline+Hipericin - fertile women | – | – |
| 2- Gamaline+Hipericin - climateric women | – | – |
| 3- Gamaline- control - fertile women | – | – |
| 4 - Gamaline control - climateric women | – | – |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Only women from 25 to 55 years old with PMS symptoms
Key inclusion criteria (2 listed)
- climacteric pre-menopausal women between 45 e 55 anos
- women between 25 e 44 anos
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karla F Deud José, Pharm PhD study chair
Phytopharm Consulting Brazil - karla@phytopharm.com.br
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Edema and Depression, run by Phytopharm Consulting Brazil at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carla Vanin, MD MSc PhD (+55 51 99628061, carlavanin@terra.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2011.