Efficacy Study of Zeller Entspannung Film Coated Tablets on Acute Stress

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

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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