Pilot Study on the Efficacy of Pascoflair in an Acute Stressful Situation (TSST) - Full Text View

Purpose

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

Condition	Intervention	Phase
Healthy Stress	Drug: Passiflora incarnata Drug: Placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized, Double Blind, Placebo-controlled Pilot Study on the Efficacy of Passiflora Incarnata L. in an Acute Stressful Situation

Resource links provided by NLM:

MedlinePlus related topics: Anxiety

Drug Information available for: Passiflora

U.S. FDA Resources

Further study details as provided by Pascoe Pharmazeutische Praeparate GmbH:

Primary Outcome Measures:

VAS insecurity [ Time Frame: 1 day ] [ Designated as safety issue: No ]
The primary objective is to assess effects of P. incarnata on psychological stress measured by Visual Analogue Scales (VAS; Bond and Lader 1974) by comparing scores collected before, during and after stress exposure between the P. incarnata and a placebo group. In this study, psychological stress is defined as stress perception, anxiety and insecurity. These three variables are determined simultaneously in the study before, during and after the stress test.
VAS anxiety [ Time Frame: 1 day ] [ Designated as safety issue: No ]
The primary objective is to assess effects of P. incarnata on psychological stress measured by Visual Analogue Scales (VAS; Bond and Lader 1974) by comparing scores collected before, during and after stress exposure between the P. incarnata and a placebo group. In this study, psychological stress is defined as stress perception, anxiety and insecurity. These three variables are determined simultaneously in the study before, during and after the stress test.
VAS stress perception [ Time Frame: 1 day ] [ Designated as safety issue: No ]
The primary objective is to assess effects of P. incarnata on psychological stress measured by Visual Analogue Scales (VAS; Bond and Lader 1974) by comparing scores collected before, during and after stress exposure between the P. incarnata and a placebo group. In this study, psychological stress is defined as stress perception, anxiety and insecurity. These three variables are determined simultaneously in the study before, during and after the stress test.

Secondary Outcome Measures:

Saliva cortisol [ Time Frame: 1 day ] [ Designated as safety issue: No ]
will be collected 2 min. prior to the stress test and 1, 10, 20, 30, 45 and 60 min. after the TSST
Serum cortisol [ Time Frame: 1 day ] [ Designated as safety issue: No ]
2 min. prior to and 1 min. after the TSST
ACTH [ Time Frame: 1 day ] [ Designated as safety issue: No ]
ACTH - Adrenocorticotropes Hormon - 2 min. prior to and 1 min. after the TSST
Epinephrine [ Time Frame: 1 day ] [ Designated as safety issue: No ]
2 min. prior to and 1 min. after the TSST
Norepinephrine [ Time Frame: 1 day ] [ Designated as safety issue: No ]
2 min. prior to and 1 min. after the TSST
State anxiety (STAI-X1) Questionnaire [ Time Frame: 1 day ] [ Designated as safety issue: No ]
The STAI-X1 measures state anxiety (one scale). Answers are given on a four-point rating scale ranging from 1 = "not at all" to 4 = "very true". The questionnaire is used as baseline measurement at V2. In addition, it is also employed before and immediately after the stress test at V3 to assess changes in state anxiety. Assess V2, before and after V3
POMS Questionnaire [ Time Frame: 1 day ] [ Designated as safety issue: No ]
The POMS assesses the four states depression/anxiety, fatigue, vigor and hostility (4 scales). High vigor scores reflect a positive mood whereas high scores in the other subscales indicate negative mood. Subjects rate their mood state on a 7-point rating scale ranging from 1 = "not at all" to 7 = "very strongly". The questionnaire is completed on V2 and V3.
MDBF Questionnaire [ Time Frame: 1 day ] [ Designated as safety issue: No ]
The MDBF assesses the three bipolar dimensions good/bad mood, wakefulness/tiredness and calmness/agitation (3 scales). The short form of the MDBF and its parallel version (versions A and B) each consist of 12 items. Subjects rate their mood state on a 5-point rating scale ranging from 1 = "not at all" to 5 = "very true". To determine mood changes induced by the TSST, the questionnaire is completed shortly before (version A) and immediately after the TSST (version B). Assess before and after V3
LSEQ Questionnaire [ Time Frame: 1 day ] [ Designated as safety issue: No ]
The LSEQ investigates four aspects of sleep using VAS: getting to sleep, quality of sleep, awakening from sleep and behavior following awakening. The LSEQ is completed on V2 and V3.

Enrollment:	60
Study Start Date:	May 2012
Study Completion Date:	August 2012
Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo Placebo arm	Drug: Placebo 3 x 1 ablet per day for 3 days Other Name: Placebo
Active Comparator: Verum Verum arm - Pascoflair 425mg	Drug: Passiflora incarnata 3 x 1 tablet per day for 3 days Other Name: Pascoflair 425mg coated tablets

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

Ages Eligible for Study:	25 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01665170

Locations

Germany
Juliane Hellhammer
Trier, Germany, 54296

Sponsors and Collaborators

Pascoe Pharmazeutische Praeparate GmbH

Daacro

Investigators

Principal Investigator:

Michael Clemens, MD, Prof

Klinikum Mutterhaus der Borromäerinnen GmbH, Feldstr. 16, 54290 Trier

More Information

No publications provided

Responsible Party:	Pascoe Pharmazeutische Praeparate GmbH
ClinicalTrials.gov Identifier:	NCT01665170 History of Changes
Other Study ID Numbers:	178 S11 PF, 2011-006129-17
Study First Received:	August 1, 2012
Last Updated:	August 24, 2012
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Pascoe Pharmazeutische Praeparate GmbH:

Pascoflair
tsst
passiflora incarnata
non smoking male
and female volunteers

ClinicalTrials.gov processed this record on May 16, 2013