Passion flower and stress
Phase 1
- Conditions
- Since only healthy volunteers will be included in this study, there is no medical condition to be examined. The indication for PASCOFLAIR® is nervous restlessness, a subclinical state of stress-sensitivity.Therapeutic area: Psychiatry and Psychology [F] - Psychological processes [F02]
- Registration Number
- EUCTR2011-006129-17-DE
- Lead Sponsor
- PASCOE Pharmazeutische Präparate GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
healthy, non-smoking, 25-45, BMI>19<30, signed informed consent, females: oral contraceptives
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
condition or medication that could put the subject at risk or interfere with the accuracy of the study results, participation in another clinical study, ability to speak for oneself lacks or can be doubted, women: pregnant or lactating
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To investigate the effect of PASCOFLAIR® on psychological stress during an acute psychosocial stress test. For evaluation of psychological stress, the three variables stress perception, anxiety and insecurity are used.;Secondary Objective: To investigate the effect of PASCOFLAIR® on general wellbeing, anxiety and sleep as well as on the physiological stress response to the stress test.;Primary end point(s): stress perception, anxiety and insecurity rated on Visual Analogue Scales;Timepoint(s) of evaluation of this end point: before, during and after stress test
- Secondary Outcome Measures
Name Time Method Secondary end point(s): sleep quality (1), anxiety (2) and mood (1, 2); serum & saliva cortisol, plasma ACTH and catecholamines (2), heart rate, pulse transit time, sympathovagal balance, skin conductance (3);Timepoint(s) of evaluation of this end point: (1) before and after treatment; (2) before and after the stress test; (3) before, during and after the stress test