drugset / Trial / NCT04093271

Investigating the Efficacy of Rest-ZZZ Formula in Healthy Participants With Difficulty Falling Asleep or Staying a Sleep

NCT04093271

Phase 1 Completed 27 enrolled LifeSeasons Inc. KGK Science Inc. · collab
RandomizedCrossoverQuadruple-blindOther

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

Timeline

Start
2019-09-24
Primary completion
2019-12-23
Completion
2019-12-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Diphenhydramine Unknown

Indications

No indication recorded.