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

Pascoe Natural Healthcare

Status and phase

Completed

Phase 3

Conditions

Healthy

Stress

Treatments

Drug: Passiflora incarnata

Drug: Placebo

Study type

Interventional

Funder types

NETWORK

Industry

Identifiers

NCT01665170

2011-006129-17 (EudraCT Number)

178 S11 PF

Details and patient eligibility

About

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

Full 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.

Enrollment

60 patients

Sex

All

Ages

25 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.