At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo-controlled, Cross-over, Pilot Study to Investigate the Efficacy of Rest-ZZZ Formula in Healthy Participants With Difficulty Falling Asleep or Staying a Sleep
In Brief
A Phase 1 clinical trial evaluating Rest-ZZZ, Active Comparator - Diphenhydramine HCl, and 1 other intervention for Sleep and Healthy. Completed, enrolled 27 participants across 1 site.
Detailed Summary
A randomized, double-blind, placebo-controlled, cross-over pilot study to investigate the efficacy of Rest-ZZZ in healthy participants with difficulty falling asleep or staying a sleep. The study will have 3 study periods. During each study period, eligible participants will consume either Rest-ZZZ, comparator product, or placebo for 7 days during each study period (1 product per study period), with a 1-week washout period in between each period. The primary objective is the comparison in sleep quality using a sleep quality questionnaire from pre-supplement to Day 7 between the Rest-ZZZ, comparator, and placebo. Other study outcomes include the change in quality of life, profile of mood states (POMS), and safety outcomes such as vital signs, clinical chemistry and hematological markers
Study Details
Timeline
Interventions
A dietary supplement containing melatonin, valerian root, chamomile, passion flower, GABA, hawthorn berry, and lemon balm
DIN 02229960 encapsulated for blinding purposes
No active ingredients