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Randomized, Double-Blind, Placebo-Controlled, Single-Center Clinical Study with a Run-in Baseline, Daily Diary Log, and Validated Questionnaires (Greene GCS) with Oral Dietary Supplement
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Instructions: Take 1 capsule when having a hot flash at the onset of a hot flash (not to exceed 1 capsule/day). Only treat 1 hot flash during a 24-hour period. |
|
| Dietary Supplement with actives | Active Comparator | Instructions: Take 1 capsule when having a hot flash at the onset of a hot flash (not to exceed 1 capsule/day). Only treat 1 hot flash during a 24-hour period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | Placebo |
| |
| Dietary Supplement with actives |
| Measure | Description | Time Frame |
|---|---|---|
| 24 hour effects following single dose of Mellow Menopause - Hot Flashes | To assess the efficacy for improvement of a treatment product on menopausal vasomotor symptoms (hot flashes- intensity, duration) within 24 hours compared to placebo through daily diary data and MenoLife application based diary. | From baseline Day 7 to Treatement Day 1 (Day 8 of study) |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of overall daily menopausal vasomotor symptoms | To assess the efficacy for improvement of overall daily menopausal vasomotor symptoms compared to placebo through daily diary data and MenoLife diary though 7 days. Data in the Daily diary and MenoLife Diary will be compared between the active supplement and placebo groups across different time points. | from enrollment to end of study at Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Assess Menopause symptoms using the Greene Climacteric Scale (GCS). | To assess the efficacy of the investigation product on menopause symptoms using a validated questionnaire Greene Climacteric Scale (GCS). Data from the GCS Score will be compared between the active supplement and placebo groups across different time points. | from enrollment to end of study at Day 15 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco Research Institute | Recruiting | San Francisco | California | 94132 | United States |
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| Dietary Supplement |
Dietary supplement containing EstroG-100 and GABA |
|
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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