An interventional study of Placebo and Treatment in Sleep, sponsored by Pharmanex. Status unknown. Open to participants aged 20 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-02.
Sponsored by Pharmanex (part of Nu Skin Enterprises) · Not applicable, Interventional, and Treatment
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.
Pharmanex is the lead sponsor of 23 studies on the registry; 2 are open to participants now.
First submitted after Pharmanex became part of Nu Skin Enterprises.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Powder that is to be mixed into 3oz. of water, 30-60 minutes before going to bed
Dietary Supplement: Treatment
Placebo that is 2 softgels that will be taken with water, 30-60 minutes prior to going to bed.
Other: Placebo
Two softgels to be taken with water that is to be consumed approximately 30-60 minutes before going to bed
Also known as: Placebo 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
Also known as: Supplement for supporting sleep
Change from baseline sleep quality index
Change from baseline in validated Pittsburgh Sleep Quality Index (0-21, higher number indicates poorer quality)
Time frame: Baseline, Day 1, Day 7, Day 28
Change from baseline sleep duration and quality from diary
Change from baseline with Daily Sleep Diary
Time frame: Baseline and Daily for 28 days
Change from baseline perceived stress scale
Change from baseline with validated perceived stress questionnaire
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Baseline, Day 7, and Day 28
Change in diastolic blood pressure measurement (safety measure)
Change from baseline diastolic blood pressure changes using sphygmomanometer
Time frame: Baseline and Day 28
Change in systolic blood pressure measurement (safety measure)
Change from baseline systolic blood pressure changes using sphygmomanometer
Time frame: Baseline and Day 28
Change in body weight
change from baseline in body weight as measured in pounds
Time frame: Baseline and Day Day 28
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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