Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to Examine the Benefits of an Oral Product in Subjects With Menopausal Symptoms. The main questions it aims to answer are:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Oral dietary supplement. 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 Proprietary Herbal Extract Blend and GABA | Active Comparator | Oral dietary supplement. 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 |
|---|---|---|---|---|
| Dietary Supplement with Proprietary Herbal Extract Blend and GABA | Dietary Supplement | Eligible subjects will receive active product to take daily for seven days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Daily Diary - 24hr | To assess changes in menopausal vasomotor symptoms scores within 24 hours compared to placebo through Daily Diary. | from enrollment to the end of study at seven days |
| Mobile App - 24hr | To assess changes in menopausal vasomotor symptoms scores within 24 hours compared to placebo through Mobile Application. | from enrollment to the end of study at seven days |
| Measure | Description | Time Frame |
|---|---|---|
| Daily Dairy - Days 1-6 | To assess changes in menopausal vasomotor symptoms, stress/anxiety, mood swings, and headaches scores compared to placebo through days 1-6 | from enrollment to the end of study at seven days |
| Mobile App - Days 1-6 |
| Measure | Description | Time Frame |
|---|---|---|
| Pittsburgh Sleep Quality Index (PSQI) - Day 7 | To assess changes on mood, stress and sleep scores at 7 days post treatment | from enrollment to the end of study at seven days |
| Perceived Stress Scale (PSS) - Day 7 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Francisco Research Institute | San Francisco | California | 94127 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Double-Blind
| Placebo | Other | Eligible subjects will receive Placebo to take daily for seven days |
|
To assess changes in menopausal vasomotor symptoms, stress/anxiety, mood swings, and headaches scores compared to placebo through days 1-6
| from enrollment to the end of study at seven days |
| Green Climacteric Scale (GCS) - Days 1-6 | To assess changes in stress/anxiety, mood swings, and headaches scores compared to placebo through days 1-6 | from enrollment to the end of study at seven days |
| Menopause-Specific Quality of Life (MENQOL) - Days 1-6 | To assess changes in menopausal vasomotor symptoms, stress/anxiety, mood swings, and headaches scores compared to placebo through days 1-6 | from enrollment to the end of study at seven days |
To assess changes on mood, stress and sleep scores at 7 days post treatment
| from enrollment to the end of study at seven days |
| Profile of Mood States questionnaire (POMS) - Day 7 | To assess changes on mood, stress and sleep scores at 7 days post treatment | from enrollment to the end of study at seven days |
| D000613 |
| Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |