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

NCT05684523 | Completed Phase 4 Results

• 1 other identifier: Ze 91019-04-2022-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Study Feasibility as Measured by the Number of Participants Who Completed the Study as Per Protocol

  Descriptive analysis considering number of patients through recruitment, screening, enrolment, main study phase, problems with handling Fitbit device, diary and SoSci survey

  21 days

Secondary Outcomes (4)

• Total Sleep Duration Per Day

  each day for 21 days

• Total Duration in Bed Per Day

  each day for 21 days

• Working Memory at Daytime: Number of Correctly Remembered Digits

  each day for 21 days

• Reaction Time at Daytime

  each day for 21 days

Study Arms (2)

Redormin® 500

EXPERIMENTAL

fixed combination of valerian and hops dry extract, 500 mg, once daily for 21 days

Drug: Valerian-Hop Extract

Placebo

PLACEBO COMPARATOR

matching placebo, once daily for 21 days

Drug: Placebo

Interventions

Valerian-Hop Extract DRUG

herbal drug

Also known as: Redormin® 500

Redormin® 500

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy
• Male or female
• Age: 18-65 years old
• Occasional sleep problems (in average 1-2 nights per week, PSQI-score \>5) with accompanying subjective cognitive problems (in average at least on one day per week) in the last month
• Fluent in German
• Able and willing to give written informed consent and comply with the requirements of the study protocol

You may not qualify if:

• DSM-V diagnosis of insomnia
• History of neurologic disorder
• Current psychiatric disorder
• Presence of moderately severe or severe depressive disorder (PHQ-9 ≥ 15)
• Current chronic intake of prescription drugs with psychotropic effects
• Current intake of OTC drugs for sleep or mood problems
• Presence of pain condition
• Diabetes mellitus
• Coronary Heart Disease

Sponsors & Collaborators

• Max Zeller Soehne AG: lead
• University of Basel: collaborator

Study Sites (1)

Research Platform MCN University of Basel

Basel, Canton of Basel-City, 4055, Switzerland

Location

Related Publications (1)

• Schicktanz N, Gerhards C, Schlitt T, Aerni A, Muggler E, de Quervain D, Papassotiropoulos A, Boonen G, Drewe J, Butterweck V. Effects of a Valerian-Hops Extract Combination (Ze 91019) on Sleep Duration and Daytime Cognitive and Psychological Parameters in Occasional Insomnia: A Randomized Controlled Feasibility Trial. Brain Behav. 2025 Jun;15(6):e70600. doi: 10.1002/brb3.70600.

  PMID: 40462685 RESULT

MeSH Terms

Conditions

Sleep Disorders, Circadian Rhythm; Cognitive Dysfunction

Interventions

Hova

Condition Hierarchy (Ancestors)

Chronobiology Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Occupational Diseases; Mental Disorders; Cognition Disorders; Neurocognitive Disorders

Results Point of Contact

• Title: Veronika Butterweck
• Organization: Max Zeller Soehne AG

veronika.butterweck@zellerag.ch

+41714660447

Study Officials

• Christiane Gerhards

  University of Basel

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: matching placebo
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: randomized, double blind, placebo-controlled

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: January 13, 2023
• Study Start: March 1, 2023
• Primary Completion: December 20, 2023
• Study Completion: December 20, 2023
• Last Updated: June 11, 2026
• Results First Posted: June 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)