A Phase 1 interventional study of Sleep Supplements and Placebo in Sleep and Sleep Quality, sponsored by Pharmavite LLC. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by Pharmavite LLC · Phase 1, Interventional, and Treatment
This is a randomized, double-blind, placebo-controlled, 5-arm parallel-group study to evaluate the effects of 4 nutritional supplements on sleep over a 12 week period in healthy U.S. adults.
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.
This study's enrollment of 376 is above the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Pharmavite LLC is the lead sponsor of 6 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Has any significant acute or chronic coexisting health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history. Excluded health conditions include:
Currently or recently (in the past 4 weeks) taking a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results. Prohibited medications include:
Participants served Sleep Supplement 1
Dietary Supplement: Sleep Supplements
Participants served Sleep Supplement 2
Dietary Supplement: Sleep Supplements
Participants served Sleep Supplement 3
Dietary Supplement: Sleep Supplements
Participants served Sleep Supplement 4
Dietary Supplement: Sleep Supplements
Participants served placebo
Other: Placebo
Sleep supplements
Matching placebo
PROMIS Sleep Disturbance 8A
Perceived sleep quality
Time frame: 0, 4, 8, and 12 weeks
PROMIS Sleep Related Impairment 8A
Perceived functional impairments during wakefulness associated with sleep problems or impaired alertness.
Time frame: 0, 4, 8, and 12 weeks
Insomnia Severity Index (ISI)
Severity of sleep difficulties and satisfaction with sleep
Time frame: 0, 4, 8, and 12 weeks
Depression, Anxiety, and Stress Scale - 21 Items (DASS-21)
Severity of general psychological distress and symptoms related to depression, anxiety, and stress
Time frame: 0, 4, 8, and 12 weeks
Bristol Stool Scale (BSS)
Stool frequency and consistency
Time frame: 0, 4, 8, and 12 weeks
Safety Objectives
Occurrence of any Adverse Events (AEs/SAEs)
Time frame: 0, 4, 8, and 12 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Sleep Initiation and Maintenance Disorders→
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