Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Herbarium Laboratorio Botanico Ltda | INDUSTRY |
| Complexo Hospitalar Santa Casa de Misericordia de Porto alegre | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Climacteric Complains bring to women many problems for living a normal life - hot flashes, irritation are 2 of many problems and the mixture of those 2 plant extract must bring a new horizon for this part of time.
2 herbal extracts used in general alone will be running together for the best climacteric women on quality of life.
The investigators will test the mixture already in the market as GynoPlus and RemifeminPlus, but as each extract has its own particularities the investigators will try CIM/HIP as a unique formulation versus Clifemin® as control and Aplause® as comparator.
This protocol was performed for the best of our volunteers.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cimicifuga+Hiperico | Experimental | 80 + 450 mg / tablet |
|
| Cimicifuga Herbarium | Active Comparator | 80 mg / caps |
|
| Aplause® | Active Comparator | 20 mg / tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cimicifuga + Hiperico | Drug | 1 tablet, 80+450mg/tablet, twice a day for 1-3 months 1 tablet, 80+450mg/tablet, once a day for 3-6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Menopause Rating Scale | Climacteric Symptoms Evaluation - "MRS - Menopause Rating Scale* | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton's Depression Scale | Questionair for Depression Symptoms | 8 months |
| WHOQOL | Starting Point (T-2) and Ending Point (T6) | 8 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marli Chaves, Secretary | Contact | +55 51 8130-8454 | contato@phytopharm.com.br | |
| Karla F Deud José, PharmD PhD | Contact | +55 51 9279-3075 | karla@phytopharm.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Karla F Deud José, Pharm PhD | Phytopharm Consulting Brazil - karla@phytopharm.com.br | Study Chair |
| Carla Vanin, MD MSc PhD | Federal University of Health Science of Porto Alegre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ISCMPA's Gynecology Ambulatory | Porto Alegre | Rio Grande do Sul | 90020-090 | Brazil |
Not provided
| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| C000713173 | black cohosh root extract |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Cimicifuga Herbarium | Drug | 2 caps, 80mg/caps, once a day for 1-3 months 1 caps, 80mg/caps, once a day for 3-6 months |
|
| Aplause® | Drug | 4 tablets, 20mg/tablet, twice a day for 1-3 months 2 tablets, 20mg/tablet, twice a day for 3-6 months |
|
| Health Numbers | Starting Point (T0, T1, T3 and T6) | 8 months (T-2 to T6) |
| Raquel P Dibi, MD MSc | Irmandade Santa Casa de Misericórdia de Porto Alegre | Principal Investigator |