Passion flower and stress

A randomized, double blind, placebo-controlled pilot study on the efficacy of Passiflora incarnata L. in an acute stressful situation - P. incarnata and stress - P1-2011

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-006129-17-DE

Enrollment

Registered

2012-03-08

Start date

2012-05-18

Completion date

Unknown

Last updated

2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Since only healthy volunteers will be included in this study, there is no medical condition to be examined. The indication for PASCOFLAIR® is nervous restlessness, a subclinical state of stress-sensitivity.

Interventions

Trade Name: PASCOFLAIR® 425mg Pharmaceutical Form: Coated tablet INN or Proposed INN: Passiflora incarnata dry extract preparation (5-7:1) CAS Number: 8001000-82-6 Other descriptive name: PASSIFLORA I

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: healthy, non-smoking, 25-45, BMI>19=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: condition or medication that could put the subject at risk or interfere with the accuracy of the study results, participation in another clinical study, ability to speak for oneself lacks or can be doubted, women: pregnant or lactating

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the effect of PASCOFLAIR® on psychological stress during an acute psychosocial stress test. For evaluation of psychological stress, the three variables stress perception, anxiety and insecurity are used.;Secondary Objective: To investigate the effect of PASCOFLAIR® on general wellbeing, anxiety and sleep as well as on the physiological stress response to the stress test.;Primary end point(s): stress perception, anxiety and insecurity rated on Visual Analogue Scales;Timepoint(s) of evaluation of this end point: before, during and after stress test	—

Measure

Time frame

Main Objective: To investigate the effect of PASCOFLAIR® on psychological stress during an acute psychosocial stress test. For evaluation of psychological stress, the three variables stress perception, anxiety and insecurity are used.;Secondary Objective: To investigate the effect of PASCOFLAIR® on general wellbeing, anxiety and sleep as well as on the physiological stress response to the stress test.;Primary end point(s): stress perception, anxiety and insecurity rated on Visual Analogue Scales;Timepoint(s) of evaluation of this end point: before, during and after stress test

—

Secondary

Measure	Time frame
Secondary end point(s): sleep quality (1), anxiety (2) and mood (1, 2); serum & saliva cortisol, plasma ACTH and catecholamines (2), heart rate, pulse transit time, sympathovagal balance, skin conductance (3);Timepoint(s) of evaluation of this end point: (1) before and after treatment; (2) before and after the stress test; (3) before, during and after the stress test	—

Countries

Germany

Contacts

Public ContactClinical Trial Information

DAaCRO GmbH und Co. KG

info@daacro.de496519120494

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026