Efficacy Study of Zeller Entspannung Film Coated Tablets on Acute Stress

Max Zeller Soehne AG72 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

The Primary Condition Studied for This Trial is Acute Stress

Interventions

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 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

Outcomes

Primary Outcomes

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