Efficacy Study of Zeller Entspannung Film Coated Tablets on Acute Stress
- Conditions
- The Primary Condition Studied for This Trial is Acute Stress
- Interventions
- Registration Number
- NCT02189239
- Lead Sponsor
- Max Zeller Soehne AG
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 72
- Age:18 - 45 years
- Written informed consent
- Male gender
- 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 exclusion criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description No Treatment No Treatment No medication intake. Placebo tablets Placebo 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. Zeller Entspannung film coated tablets Zeller Entspannung film coated tablet 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.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Phase I Research Unit, University Hospital Basel
🇨🇭Basel, Switzerland