Safety and Efficacy Study of Gamaline+Hipericin in PMS (GH)

Phytopharm Consulting Brazil

Status: Unknown

Conditions: Edema; Irritability; Hot Flashes; Depression; Anxiety

Study type: Observational

Funder types: Other; NETWORK; Industry

Identifiers

NCT01283568

GAMALINEHIPERICIN

Details and patient eligibility

About

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).

Full 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

Enrollment: 240 estimated patients

Sex: Female

Ages: 25 to 55 years old

Volunteers: No 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

Trial design

240 participants in 4 patient groups

1 - Gamaline+Hipericin - fertile women

2- Gamaline+Hipericin - climateric women

3- Gamaline- control - fertile women

4 - Gamaline control - climateric women