Efficacy Study of Zeller Entspannung Film Coated Tablets on Acute Stress
NCT ID: NCT02189239
Last Updated: 2015-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
72 participants
INTERVENTIONAL
2015-01-31
2015-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
A third arm including no treatment is tested as well. Approximately 72 healthy volunteers will be included into this randomized, double blind study. Study duration will be 7 days, study medication intake will be over 4 days: participants will take the medication one tablet three times a day (morning, midday, evening) the first 3 days, whereas on day 4 only two tablets will be taken (morning and midday).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Improvement of Dry Mouth Sufferers After Using an Experimental Dry Mouth Rinse Compared to a Water Control
NCT04189081
Stress Biomarkers:Attaching Biological Meaning to Field Friendly Salivary Measures
NCT01673087
Salivary Cortisol Measurements by Mass Spectrometry
NCT02162706
Examining Stress Salivary Biomarkers in Pediatric Patients Undergoing Dental Procedures
NCT06730425
Real-time Monitoring of Cortisol - Comparison of Cortisol Levels in Four Biological Fluids
NCT06008184
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Zeller Entspannung film coated tablets
Relaxing film coated tablets, 570 mg (Zeller Entspannung Filmtabletten), 3x1 tablet per day for the first three days (morning, midday, evening), at day four 2x1 tablet (morning, midday) preferably during meals with a glass of water.
Zeller Entspannung film coated tablet
Placebo tablets
Placebo medication is identical in presentation, color and shape, 3x1 tablet per day for the first three days (morning, midday, evening), at day four 2x1 tablet (morning, midday) during meals with a glass of water.
Placebo
No Treatment
No medication intake.
No Treatment
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Zeller Entspannung film coated tablet
Placebo
No Treatment
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Written informed consent
* Male gender
Exclusion Criteria
* Smoking
* Any clinically relevant hepatic disorder
* Any clinically relevant renal disorder
* Any clinically relevant cardiac disorder
* Any clinically relevant respiratory disease (e.g. Asthma)
* Diabetes mellitus
* Known allergies to trial medication and excipients
* Alcohol or other drug abuse (e.g. cannabis)
* Concomitant participation in another clinical trial or \<4 weeks ago
* Participation in any psychotherapy
* Already participated in a TSST
18 Years
45 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Max Zeller Soehne AG
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Phase I Research Unit, University Hospital Basel
Basel, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Ze 185-4-2014-02
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.