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

NCT ID: NCT01665170

Last Updated: 2015-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2012-08-31

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.

Conditions

Healthy; Stress

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Placebo arm

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

3 x 1 ablet per day for 3 days

Verum

Verum arm - Pascoflair 425mg

Group Type: ACTIVE_COMPARATOR

Passiflora incarnata

Intervention Type: DRUG

3 x 1 tablet per day for 3 days

Interventions

Passiflora incarnata

3 x 1 tablet per day for 3 days

Intervention Type: DRUG

Placebo

3 x 1 ablet per day for 3 days

Intervention Type: DRUG

Other Intervention Names

Pascoflair 425mg coated tablets

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Daacro

NETWORK

Sponsor Role: collaborator

Pascoe Pharmazeutische Praeparate GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Clemens, MD, Prof

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Juliane Hellhammer

Trier, , Germany

Countries

Germany

Other Identifiers

2011-006129-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

178 S11 PF

Identifier Type: -

Identifier Source: org_study_id