Pilot Study on the Efficacy of Pascoflair in an Acute Stressful Situation (TSST)

NCT01665170 | Completed Phase 3 Results

• 2 other identifiers: 178 S11 PF2011-006129-17
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy; Stress

Keywords

Pascoflair; tsst; passiflora incarnata; non smoking male; and female volunteers

Outcome Measures

Primary Outcomes (3)

• VAS Insecurity (During)

  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. Minimum = 0 mm; Maximum = 100 mm, higher value = represent a worsend outcome.

  during stress test = Visite 3

• VAS Anxiety (During)

  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. Minimum = 0 mm; Maximum = 100 mm, higher value = represent a worsend outcome.

  during stress test = Visite 3

• VAS Stress Perception (During)

  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. Minimum = 0 mm; Maximum = 100 mm, higher value = represent a worsend outcome.

  during stress test = Visite 3

Secondary Outcomes (25)

• Serum Cortisol (Pre-post Comparison)

  1 day

• ACTH (Pre-post Comparison)

  1 day

• Epinephrine (Before)

  1 day

• Norepinephrine (Before)

  before stress test

• State Anxiety (STAI-X1) Questionnaire

  1 day

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo arm

Drug: Placebo

Verum

ACTIVE COMPARATOR

Verum arm - Pascoflair 425mg

Drug: Passiflora incarnata

Interventions

Passiflora incarnata DRUG

3 x 1 tablet per day for 3 days

Also known as: Pascoflair 425mg coated tablets

Verum

Placebo DRUG

3 x 1 ablet per day for 3 days

Placebo

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Pascoe Pharmazeutische Praeparate GmbH: lead
• Daacro: collaborator

Study Sites (1)

Juliane Hellhammer

Trier, 54296, Germany

Location

Results Point of Contact

• Title: Dr. Gabriele Weiß
• Organization: PASCOE pharmazeutische Präparate GmbH

klinischeforschung@pascoe.de

0641-7960

Study Officials

• Michael Clemens, MD, Prof

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2012
• First Posted: August 15, 2012
• Study Start: May 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: December 9, 2015
• Results First Posted: December 9, 2015

Record last verified: 2015-11

Locations

DE (1)