Neurexan to be effective in fostering mental balance by reducing tension and nervousness during acute stress setting in healthy probands MedDRA version: 15.1 Level: LLT Classification code 10042219 Term: Stress test System Organ Class: 100000004848
Conditions
Interventions
Trade Name: Neurexan
Product Name: Neurexan
Pharmaceutical Form: Tablet
INN or Proposed INN: COFFEA ARABICA
CAS Number: 8000050-74-0
Other descriptive name: COFFEA ARABICA
Concentration unit: mg milli
Sponsors
Biologische Heilmittel Heel GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For inclusion in the study, volunteers must fulfil all of the following criteria: 1. Provide written informed consent 2. Healthy male or female 3. age between 31 to 59 years 4. fluent in German language 5. Ability to understand the explanations and instructions given by the study physician 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 70 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Any of the following is regarded as a criterion for exclusion from the study: 1. allergies to ingredients of Neurexan® (Passiflora incarnata, Avena sativa, Coffea arabica, Zincum isovalerianicum, lactose monohydrate, magnesium stearate) or Placebo 2. lactose intolerance 3. use of any psychological stress-management intervention within the last 4 weeks 4. sick leave for any reason 5. participation in any other clinical study 3 months prior to Screening Visit 6. current or recent (3 months prior to Screening Visit) history of substance abuse or drug dependence including nicotine and alcohol (as verified in the respective IDCL list) 7. smokers 8. alcohol intake within last 24 hours (before Baseline Visit V3) 9. shift workers or work regularly during night time 10. use of any psychotropic medication or suffering from severe psychiatric illness needing acute intervention 11. BMI > 30 kg/m2 12. currently pregnant (verified by urine pregnancy test) or lactating 13. participation in a previous TSST study 14. high chronic stress as verified with the TICS - SSCS (a score of = 23 on the screening scale for chronic stress meets the criterion of being chronically stressed) 15. major mental disorder as verified with the IDCL (depressive episode, panic disorder, social phobia, obsessive-compulsory disorder; alcohol dependency; schizophrenia and mania.) 16. employee of the Sponsor, one of the investigators or the CRO 17. use of any concomitant medication except contraceptives 18. any somatic disease or other condition the Investigator or their duly assigned representatives believes may affect the ability of the individual to complete the study or the interpretation of the study results 19. Individuals whose ability to speak for themselves lacks or can be doubted
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is the efficacy of Neurexan® on tension and nervousness perception using visual analogue scales (VAS) when study participants undergo an emotional stressful condition as compared to Placebo. The test method for this study is the TSST protocol. ;Secondary Objective: Secondary objectives of the study are stress-sensitive psychological and physiological measures in response to acute stress: • stress-related biomarkers such as plasma and saliva cortisol, a-amylase, Adrenocorticotropic Hormone (ACTH), catecholamines, NK cells • parameters of Autonomous Nervous System (ANS) such as blood pressure (BP), heart rate and heart rate variability (HRV) • state anxiety and stress perception measured by State-Trait Anxiety Inventory (STAI) • physiological questionnaire (modified somatic SCL90);Primary end point(s): • Area under the curve (AUC) of VAS tension values from T1 until T15. • Area under the curve (AUC) of VAS nervousness values from T1 until T15. For each of the two AUCs an Analysis of Covariance (ANCOVA) model including gender and site as qualitative factors and the respective VAS value (i.e. tension or nervousness) at time point T1 (-210 min) as a covariate will be analysed to test for treatment differences ;Timepoint(s) of evaluation of this end point: -210 min -180 min -150 min -120 min -90 min -60 min -30 min -15 min +15 min +25 min +40 min +55 min +70 min +100 min | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Changes in tension and nervousness VAS at all time points after time point T1 (-210 min) • Changes in plasma and saliva cortisol and a-amylase, ACTH, catecholamines norepinephrine (NE) and epinephrine (E) • Changes in NK cells (subgroup) • Changes in BP, heart rate and HRV • State anxiety and stress perception measured by STAI-X1 • Incidence of AEs All parameters will be descriptively summarised by treatment and assessment time. The AEs and vital signs will be summarised by treatment group. ;Timepoint(s) of evaluation of this end point: -60 min to +100 min, AEs from -180 min to +100 min | — |
Countries
Germany
Contacts
Public ContactProject Management
Theorem Clinical Research GmbH & Co. KG
Outcome results
None listed