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| Name | Class |
|---|---|
| Dermatology Consulting Services, High Point NC | OTHER |
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Sleep is essential for health and wellness. Sleep disruption can occur due to emotional stress, advancing age, hormonal imbalance, medications, and many other causes, some of which are presently unknown. Most pharmaceutical sleep products artificially induce sedation without providing quality sleep. Thus, a need exists for safe dietary supplement to promote and support healthy sleep that will encourage restful sleep. This study will examine the efficacy, tolerance, and safety of sleep supplement as compared to a placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active: Sleep Supplement containing Magnesium and Saffron Extract | Experimental | Powder that is to be mixed into 3oz. of water, 30-60 minutes before going to bed |
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| Placebo | Placebo Comparator | Placebo that is 2 softgels that will be taken with water, 30-60 minutes prior to going to bed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | Two softgels to be taken with water that is to be consumed approximately 30-60 minutes before going to bed |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline sleep quality index | Change from baseline in validated Pittsburgh Sleep Quality Index (0-21, higher number indicates poorer quality) | Baseline, Day 1, Day 7, Day 28 |
| Change from baseline sleep duration and quality from diary | Change from baseline with Daily Sleep Diary | Baseline and Daily for 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline perceived stress scale | Change from baseline with validated perceived stress questionnaire | Baseline, Day 1, Day 7, Day 28 |
| Change from baseline Insomnia severity index | Change from baseline using validated Insomnia Severity Index (0-28, higher number indicates more severe insomnia) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in diastolic blood pressure measurement (safety measure) | Change from baseline diastolic blood pressure changes using sphygmomanometer | Baseline and Day 28 |
| Change in systolic blood pressure measurement (safety measure) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zoe D Diana, MD | Contact | 336-841-2040 | zdraelos@northstate.net |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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A double-blind, placebo controlled, parallel designed study in healthy subjects
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Products will be delivered in forms that it will not be discernable (to participant, investigator, or care provider) as to which product is active or placebo
| Treatment | Dietary Supplement | 14mg saffron extract and 250mg magnesium citrate that is powder that is mixed in 3-4 oz of water and consumed 30-60 minutes before going to bed |
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| Baseline, Day 1, Day 7, Day 28 |
| Change from baseline in restorative sleep as measured by Restorative Sleep Questionnaire (RSQ) | Change from baseline using restorative sleep questionnaire as measured by Restorative Sleep Questionnaire (RSQ) that is a 9-item scale/question assessing symptoms over the last week. The total score ranges from 0 to 100, with higher scores indicating better restorative sleep | Baseline, Day 1, Day 7, Day 28 |
| Change from baseline in mood | Change from baseline using abbreviated Profile of Mood States (POMS) is a widely used questionnaire of 24 items and four scales. Total numbers range from 0-not at all to 4-very strong | Baseline, Day 1, Day 7, Day 28 |
| Change from baseline in skin attributes | Change from baseline in skin attributes using 1-5 scale (1 strongly disagree to 5 strongly agree) with questionnaire regarding skin appearance (youthfulness, glow, evenness, hydration, etc) | Baseline, Day 7, and Day 28 |
Change from baseline systolic blood pressure changes using sphygmomanometer
| Baseline and Day 28 |
| Change in body weight | change from baseline in body weight as measured in pounds | Baseline and Day Day 28 |