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Feasibility Study on the Use of Redormin®500 on Day-time Cognition

NCT05684523 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-01-11

No results posted yet for this study

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.

Conditions

  • Sleep Disorders, Circadian Rhythm
  • Cognitive Dysfunction

Interventions

DRUG

Valerian-Hop Extract

herbal drug

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • University of Basel

    collaborator OTHER

  • Max Zeller Soehne AG

    lead INDUSTRY

Principal Investigators

  • Christiane Gerhards · University of Basel

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-01
Primary Completion
2023-12-20
Completion
2023-12-20

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05684523 on ClinicalTrials.gov