Efficacy Study of Zeller Entspannung Film Coated Tablets on Acute Stress
|ClinicalTrials.gov Identifier: NCT02189239|
Recruitment Status : Completed
First Posted : July 14, 2014
Last Update Posted : June 25, 2015
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).
|Condition or disease||Intervention/treatment||Phase|
|The Primary Condition Studied for This Trial is Acute Stress||Drug: Zeller Entspannung film coated tablet Drug: Placebo Other: No Treatment||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
Active Comparator: 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.
Drug: Zeller Entspannung film coated tablet
Placebo Comparator: 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.
Sham Comparator: No Treatment
No medication intake.
Other: No Treatment
- 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. [ Time Frame: 4 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189239
|Phase I Research Unit, University Hospital Basel|
|Basel, Switzerland, 4031|