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| Name | Class |
|---|---|
| Herbarium Laboratorio Botanico Ltda | INDUSTRY |
| Federal University of Health Science of Porto Alegre | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GAMALINE® + HIPERICIN® 25-44 years old | Experimental | Fertile women 24-44 years old with PMS symptoms |
|
| GAMALINE® 25-44 years old | Active Comparator | Fertile women 24-44 years old with PMS symptoms |
|
| GAMALINE® + HIPERICIN® 45-55 years old | Experimental | Climacteric women with PMS symptoms |
|
| GAMALINE® 45-55 years old | Active Comparator | Climacteric women with PMS symptoms |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GAMALINE® + HIPERICIN® | 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) |
|
| Measure | Description | Time Frame |
|---|---|---|
| PMS calendar | Evaluation will run daily during the 240 days, comparing the results before treatment [60 days (T-2) and 30 days (T-1)]. Starting point (T0) treatment/under prescription, till 180 days treatment (T6). | 240 days |
| LAB Tests | Blood sample tests before T0 (all arms), after T1 (30 days only for experimental group) and end of T6 (after 180 days of prescription for all arms) | T0 T1 and T6 |
| Measure | Description | Time Frame |
|---|---|---|
| WHOQOL | WHOQOL will be evaluated at T-2 and T6 where T-2 is at the first interview after inclusion and T6 is at the end point of treatment. | 06 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marli Chaves, Secretary | Contact | +55 51 8130-8454 | tpm@phytopharm.com.br | |
| Gustavo Remus, Physical Education | Contact | +55 51 9191-6535 | remus@phytopharm.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Carla Vanin, MD MSc PhD | UFCSPA-Universidade Federal de Ciências da Saúde de Porto Alegre | Principal Investigator |
| Karla F Deud José, PharmD PhD | Phytopharm Consulting Brazil | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ambulatório de Ginecologia e Obstetrícia ISCMPA | Porto Alegre | Rio Grande do Sul | 90020-090 | Brazil |
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| ID | Term |
|---|---|
| D011293 | Premenstrual Syndrome |
| D006470 | Hemorrhage |
| D004487 | Edema |
| D003863 | Depression |
| D019584 | Hot Flashes |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C004965 | hypericin |
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| GAMALINE® | Drug | GAMALINE® 900mg T0= 2 soft caps / day (1st month) T1-T6 = 1 soft caps / day (2nd - 6th month) |
|
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| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |