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The purpose of this study is to evaluate the effects of Passiflora incarnata and Isoflavone combination in relieving the symptoms associated with Climacteric Syndrome.
It is known that Hormone Therapy is recommended postmenopausal women to reduce menopausal symptoms and prevent osteoporosis frames and cardiovascular disease. However, only 30 to 40% of women still using hormone therapy.
One reason women do not continue or are reluctant to start Hormone Therapy is realizing that the prescription of hormones is not a natural situation. Therefore, there is an increased interest in the use and prescription of estrogen derived from plants, known as fitoestrogênios.
The development of a drug containing two standardized extracts was focused on two main symptoms of menopause: hot flashes and anxiety. This product comes from a longing for the doctors themselves can respond more promptly to patients who reach menopause and who already has a framework for mild to moderate anxiety.
Thus, to meet the woman who develops menopausal symptoms and that these two are highly prevalent during menopause, causing intense discomfort routine for this woman, was produced in association with Soy Passiflora aiming to control anxiety and hot flushes
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Patients enrolled in this arm will take a tablet twice a day |
|
| Passiflora incarnata and isoflavona combination | Active Comparator | Patients enrolled in this arm will take a tablet twice a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug |
| ||
| Active drug |
| Measure | Description | Time Frame |
|---|---|---|
| Menopause Rating Scale - MRS | 104 days |
| Measure | Description | Time Frame |
|---|---|---|
| Kuppperman-Blatt index | 90 days | |
| MRS scale | 90 days | |
| MENQOL |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ISBEM | São Paulo | São Paulo | 04062-003 | Brazil |
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| ID | Term |
|---|---|
| D000095485 | Bulk Drugs |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
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|
| 90 days |