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Efficacy Study of Zeller Entspannung Film Coated Tablets on Acute Stress

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02189239
Recruitment Status : Completed
First Posted : July 14, 2014
Last Update Posted : June 25, 2015
Sponsor:
Information provided by (Responsible Party):
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).


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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.
Drug: Placebo
Sham Comparator: No Treatment
No medication intake.
Other: No Treatment



Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189239


Locations
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Switzerland
Phase I Research Unit, University Hospital Basel
Basel, Switzerland, 4031
Sponsors and Collaborators
Max Zeller Soehne AG
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Responsible Party: Max Zeller Soehne AG
ClinicalTrials.gov Identifier: NCT02189239    
Other Study ID Numbers: Ze 185-4-2014-02
First Posted: July 14, 2014    Key Record Dates
Last Update Posted: June 25, 2015
Last Verified: June 2015