ClinicalTrials.Veeva

Menu

Efficacy Study of Zeller Entspannung Film Coated Tablets on Acute Stress

M

Max Zeller Söhne

Status and phase

Completed
Phase 4

Conditions

The Primary Condition Studied for This Trial is Acute Stress

Treatments

Drug: Zeller Entspannung film coated tablet
Other: No Treatment
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02189239
Ze 185-4-2014-02

Details and patient eligibility

About

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).

Enrollment

72 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

72 participants in 3 patient groups, including a placebo group

Zeller Entspannung film coated tablets
Active Comparator group
Description:
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.
Treatment:
Drug: Zeller Entspannung film coated tablet
Placebo tablets
Placebo Comparator group
Description:
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.
Treatment:
Drug: Placebo
No Treatment
Sham Comparator group
Description:
No medication intake.
Treatment:
Other: No Treatment

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems