The Primary Condition Studied for This Trial is Acute Stress
Conditions
Brief summary
The objective of the STRESS trial is to investigate in a mode of action setting the effect of Zeller Entspannung film coated tablets on saliva cortisol response versus Placebo after acute stress in healthy male volunteers. In addition, data on safety and tolerability of Zeller Entspannung will be obtained. 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).
Interventions
DRUGZeller Entspannung film coated tablet
DRUGPlacebo
OTHERNo Treatment
Sponsors
Max Zeller Soehne AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Age:18 - 45 years * Written informed consent * Male gender
Exclusion criteria
* Any acute or chronic somatic or psychiatric disorder * 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 * Any abnormal lab values suggesting diseases from
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to demonstrate in healthy male volunteers that Zeller Entspannung reduces overall saliva cortisol level (AUCg) after acute stress compared with a placebo. | 4 days |
Countries
Switzerland
Outcome results
None listed