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| Name | Class |
|---|---|
| Citruslabs | INDUSTRY |
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A combination of synergistic dietary supplements is hypothesized to significantly improve self-reported measures of menopausal symptoms when compared with a baseline without the intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Semaine Supplement | Experimental | Participants are provided with a dietary supplement and are instructed to take 1 capsule per day. Participants are to take the supplement at the same time every day. If forgotten, they are to take it with the next meal. Participants will take a well-being assessment after each month (4 surveys total including the baseline.) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaine Menopause Supplement | Dietary Supplement | Synergistic Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in perceived discomfort associated with the most common symptoms linked with perimenopause and menopause | Symptoms will be reported by the participant on a scale of perceived discomfort and will include rankings for mood, anxiety, fatigue, sleep quality, hot flashes, and libido. This survey will be based on the widely used and validated Menopause Rating Scale (MRS). The MRS will be modified to increase dynamic range by changing the response gradations from 5 to 7. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Hill | Citruslabs | Principal Investigator |
| Matthew Crane | Semaine Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Citruslabs | Santa Monica | California | 90404 | United States |
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