Clinical trial NCT01665170: Pilot Study on the Efficacy of Pascoflair in an Acute Stressful Situation (TSST)
Official title: A Randomized, Double Blind, Placebo-controlled Pilot Study on the Efficacy of Passiflora Incarnata L. in an Acute Stressful Situation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Stress
Keywords: Pascoflair
tsst
passiflora incarnata
non smoking male
and female volunteers
Lead sponsor: Pascoe Pharmazeutische Praeparate GmbH
Sponsor class: INDUSTRY
Collaborators: name: Daacro
First posted: 2012-08-15
Enrollment: 60
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A randomized, double blind, placebo-controlled pilot study on the efficacy of Passiflora incarnata L. in an acute stressful situation

Detailed description: Randomized, double-blind, placebo-controlled, single-center study During Visit 1 study information and an informed consent form are handed out. After study inclusion on Visit 2, participants are assigned to one of two groups at random and receive the test products (either Pascoflair® or placebo tablets). The 3rd visit includes the completion of questionnaires regarding wellbeing and the Trier Social Stress Test.

Eligibility criteria: Inclusion Criteria:

* Provide written informed consent;
* Healthy male and female subjects
* Non-smoker;
* Age 25 to 45 years;
* BMI ≥ 19 to ≤ 30 kg/m2

Exclusion Criteria:

* Any known allergies to the test substance;
* Any known addiction to drugs, alcohol or positive results in the drug screening test;
* Any serious general illness, ongoing or within the last 12 months;
* Any febrile illness (\> 24 hrs.) within 7 days prior to treatment;
* Any antibiotics for the last four weeks before study inclusion;
* Diabetes mellitus;
* Known heart disease, hypertension, kidney disease, significant respiratory disease, epilepsy, or rheumatoid arthritis;
* Known immunologic or infectious disease (e.g. hepatitis, tuberculosis, HIV or AIDS) which could place the subject at risk or interfere with the accuracy of the study results;
* Pregnancy or lactating;
* Current participation or participation in any type of clinical study in the past week;
* Current or past participation in a TSST study;
* Employees of the Sponsor or the CRO;
* Any other medication that, in the opinion of the Investigator is likely to affect their response to treatment;
* Clinically relevant abnormalities in physical examinations, vital signs, clinical chemistry, or haematology as judged by the Investigator;
* Any 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.

Primary outcomes:
measure: VAS Insecurity (During)
timeFrame: during stress test = Visite 3
measure: VAS Anxiety (During)
timeFrame: during stress test = Visite 3
measure: VAS Stress Perception (During)
timeFrame: during stress test = Visite 3
Secondary outcomes:
measure: Serum Cortisol (Pre-post Comparison)
timeFrame: 1 day
measure: ACTH (Pre-post Comparison)
timeFrame: 1 day
measure: Epinephrine (Before)
timeFrame: 1 day
measure: Norepinephrine (Before)
timeFrame: before stress test
measure: State Anxiety (STAI-X1) Questionnaire
timeFrame: 1 day
measure: POMS Questionnaire
timeFrame: 1 day
measure: MDBF Questionnaire
timeFrame: 1 day
measure: LSEQ Questionnaire (Getting to Sleep-Falling Asleep Easier Than Usual) - Changes From V2 to V3
timeFrame: Visite 2 (before treatment), Visite 3 (after treatment)
measure: LSEQ Questionnaire (Getting to Sleep-Falling Asleep More Quickly Than Usual] - Changes From V2 to V3
timeFrame: Visite 2 (before treatment), Visite 3 (after treatment)
measure: LSEQ Questionnaire (Getting to Sleep-Feeling More Drowsy Than Usual] - Changes From V2 to V3
timeFrame: Visite 2 (before treatment), Visite 3 (after treatment)
measure: LSEQ Questionnaire (Quality of Sleep - More Restful Than Usual] - Changes From V2 to V3
timeFrame: Visite 2 (before treatment), Visite 3 (after treatment)
measure: LSEQ Questionnaire (Quality of Sleep - Fewer Periods of Wakefulness Than Usual] Changes From V2 to V3
timeFrame: Visite 2, visite 3
measure: LSEQ Questionnaire (Awakening From Sleep- Easier Than Usual] Changes From V2 to V3
timeFrame: Visite 2 (before treatment), Visite 3 (after treatment)
measure: LSEQ Questionnaire (Awakening From Sleep- Quicker Than Usual] Changes From V2 to V3
timeFrame: Visite 2 (before treatment), Visite 3 (after treatment)
measure: LSEQ Questionnaire (Behavior Following Awakening- Feeling Alert Upon Awakening] Changes From V2 to V3
timeFrame: Visite 2 (before treatment), Visite 3 (after treatment)
measure: LSEQ Questionnaire (Behavior Following Awakening- Feeling Alert Now] Changes From V2 to V3
timeFrame: Visite 2 (before treatment), Visite 3 (after treatment)
measure: LSEQ Questionnaire (Behavior Following Awakening- Less Clumsy Balance and Coordination Upon Getting-up] Changes From V2 to V3
timeFrame: Visite 2 (before treatment), Visite 3 (after treatment)
measure: Norepinephrine (After)
timeFrame: 1 day
measure: Sympathovagal Balance (Before TSST, Sitting - 1. Measurement)
timeFrame: before TSST
measure: Sympathovagal Balance (Before TSST, Standing - 2. Measurement)
timeFrame: before TSST
measure: Sympathovagal Balance (During TSST, Preparation - 3. Measurement)
timeFrame: during TSST
measure: Sympathovagal Balance (During TSST, Interview - 4. Measurement)
timeFrame: during TSST
measure: Sympathovagal Balance (During TSST, Arithmetics - 5. Measurement)
timeFrame: during TSST
measure: Sympathovagal Balance (After TSST, Standing - 6. Measurement)
timeFrame: after TSST
measure: Sympathovagal Balance (After TSST, Sitting - 7. Measurement)
timeFrame: after TSST
Other outcomes:
Locations:
city: Trier
country: Germany
facility: Juliane Hellhammer
Study officials:
affiliation: Klinikum Mutterhaus der Borromäerinnen GmbH, Feldstr. 16, 54290 Trier
name: Michael Clemens, MD, Prof
role: PRINCIPAL_INVESTIGATOR
References: