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The objective of this study is to assess the safety and effectiveness of a dietary supplement for symptom relief in subjects with menopausal symptoms over the course of five weeks of continuous daily use.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Dietary Supplement with Actives | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | Eligible subjects will receive Placebo to take daily for five weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of symptom scores in Daily Dairy | To assess changes in symptom scores attained from product use in subjects with menopausal symptoms, including acute effects | from enrollment to the end of study at five weeks |
| Changes of symptom scores in Mobile Application | To assess changes in symptom scores attained from product use in subjects with menopausal symptoms, including acute effects | from enrollment to the end of study at five weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Menopause-Specific Quality of Life (MENQOL) Scores | To assess changes in mood and quality of life scores of the product compared to placebo | from enrollment to the end of study at five weeks |
| Changes in Green Climacteric Scale (GCS) Scores |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| See Final Report | San Francisco | California | 94127 | United States |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005680 | gamma-Aminobutyric Acid |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Dietary Supplement with Proprietary Herbal Extract Blend and GABA |
| Dietary Supplement |
Eligible subjects will receive active product to take daily for five weeks |
|
To assess changes in mood scores of the product compared to placebo
| from enrollment to the end of study at five weeks |
| Changes in Perceived Stress Scale (PSS) Scores | To assess changes in mood scores of the product compared to placebo | from enrollment to the end of study at five weeks |
| Changes in Profile of Mood States (POMS) Scores | To assess changes in mood scores of the product compared to placebo | from enrollment to the end of study at five weeks |
| Changes in Pittsburgh Sleep Quality Index (PSQI) Scores | To assess changes in sleep scores of the product compared to placebo | from enrollment to the end of study at five weeks |
| D000613 |
| Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |