At a glance
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Feasibility Study on the Use of Redormin® 500 (Ze 91019) on Day-time Cognition and Quality of Life in People With Occasional Sleep Problems
In Brief
A Phase 4 clinical trial evaluating Valerian-Hop Extract and Placebo for Sleep Disorders, Circadian Rhythm and Cognitive Dysfunction. Completed, enrolled 40 participants across 1 site.
Detailed Summary
Randomized, double-blind, parallel groups, placebo-controlled, baseline/run-in period of 21 days followed by trial period of 21 days, digital phenotyping (sleep, cognitive/psychological parameters and HRV). The aim of this study is to determine the feasibility of investigating the effects of Redormin® 500 on day-time cognition and to assess psychological parameters (subjective cognitive performance, tiredness, mood, stress level, quality of life, motivation), in people with occasional sleep problems. Sleep tracking data will be collected using consumer devices of the Charge series by Fitbit.
Study Details
Timeline
Arms & Interventions
fixed combination of valerian and hops dry extract, 500 mg, once daily for 21 days
matching placebo, once daily for 21 days
Interventions
herbal drug
Placebo