None listed
Conditions
Brief summary
This research aims to investigate the immediate calming effect of passionflower on short-term, but not long lasting, experimentally induced stress (an analogue to the real-life situations where individuals are required to attend and respond to several different stimuli simaltaneusly with varying levels of workload) in healthy adults. This study is a two-arm, placebo-controlled, double-blind, crossover trial involving a single dose of passionflower or placebo one week apart over two weeks. We hypothesize that single dose of passionflower has short-term calming effect in healthy people.
Interventions
Oral spray of passionflower (Passiflora incarnata extract, with the exract ratio of 2.68:1, 1.28 ml) - will be supplied by Douglas Pharmaceuticals Ltd. The passionflower spray will be administered under the supervision of research team member at the Massey Human Nutrition Research Unit. Participants will be required to use the passionflower spray 30 minutes before the computerised stress triggering session. The psychological stressor battery that will be used in this study is multitasking framew
Oral spray of passionflower (Passiflora incarnata extract, with the exract ratio of 2.68:1, 1.28 ml) - will be supplied by Douglas Pharmaceuticals Ltd. The passionflower spray will be administered under the supervision of research team member at the Massey Human Nutrition Research Unit. Participants will be required to use the passionflower spray 30 minutes before the computerised stress triggering session. The psychological stressor battery that will be used in this study is multitasking framework (also known as “the Defined Intensity Stressor Simulation (DISS) computerised battery”) is a performance-based, cognitively demanding stressor. The multitasking framework is an analogue to the real-life situations where individuals are required to attend and respond to several different stimuli simultaneously with varying levels of workload. The wash out period between treatments (passionflower and placebo) will be one week.
Sponsors
Massey University
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy adults between 18 and 45 years of age will be eligible for this study. Proficiency in English will be a requirement for participants (due to the nature of outcome assessment tools).
Exclusion criteria
• have psychiatric disorders (including psychotic or bipolar disorder illness, major depressive disorder, or any specific anxiety disorder), • have had either substance abuse or dependency disorder in the previous six months, including alcohol • are currently using antidepressants, mood stabilisers, antipsychotics, opioid, or analgesics • are diagnosed with known abnormal liver function and/or inflammatory diseases • have experienced adverse reactions to passionflower or any active ingredients of study materials • have regularly used passionflower in the previous 12 months • have had more than one occasion of passionflower use each week over the past month • are pregnant or trying to conceive • are breastfeeding • are regular smokers (more than one cigarette per week) • are unable to comply with the abstention of caffeinated products and exercise for two hours and alcohol for a minimum of 12 hours prior to visits
Outcome results
None listed