The Primary Condition Studied for This Trial is Acute Stress Clinical Trial
Official title:
A Phase IV, Randomised, Placebo Controlled Study to Investigate the Effects of Zeller Entspannung Film Coated Tablets on Cortisol Responses in Healthy Volunteers With Acute Stress
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).
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment