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Trial registered on ANZCTR


Registration number
ACTRN12619001461189
Ethics application status
Approved
Date submitted
8/10/2019
Date registered
22/10/2019
Date last updated
22/10/2019
Date data sharing statement initially provided
22/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Understanding the calming effect of passionflower
Scientific title
Understanding the calming effect of passionflower in healthy people
Secondary ID [1] 299474 0
None
Universal Trial Number (UTN)
U1111-1239-6109
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
State Anxiety 314697 0
Condition category
Condition code
Mental Health 313046 313046 0 0
Anxiety
Alternative and Complementary Medicine 313047 313047 0 0
Herbal remedies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 315729 0
Treatment: Other
Comparator / control treatment
Oral spray of placebo (BlackStrap Molasses) that will be identical to passionflower spray in appearance, smell and taste - will be supplied by Douglas Pharmaceuticals Ltd. The 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 placebo spray 30 minutes before the computerised stress triggering session.
Control group
Placebo

Outcomes
Primary outcome [1] 321593 0
State anxiety (will be assessed using State-Trait Anxiety Inventory, STAI)
Timepoint [1] 321593 0
Participants will be required to complete the STAI immediately before and after the computerised stressor session (baseline for the day). Thirty minutes after the completion of the baseline assessments and computerised stressor battery , participants will be given the treatment spray to use and asked to wait for another 30 minutes. Then, participants will be required to complete the STAI immediately before and after another computerised stressor session (endpoint for the day).
Secondary outcome [1] 375503 0
Mood (will be assessed using Beck Anxiety Inventory, BAI)
Timepoint [1] 375503 0
Participants will be required to complete the BAI immediately before and after the computerised stressor session (baseline for the day). Thirty minutes after the completion of the baseline assessments and computerised stressor battery , participants will be given the treatment spray to use and asked to wait for another 30 minutes. Then, participants will be required to complete the BAI immediately before and after another computerised stressor session (endpoint for the day).
Secondary outcome [2] 375505 0
Heart rate (will be assessed using wrist heart rate monitor)
Timepoint [2] 375505 0
Throughout the testing sessions - from the baseline assessments (pre-treatment assessments and computerised stressor battery) to the end of endpoint assessments (post-treatment assessments and computerised stressor battery) for the day.

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
45 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
To maintain researcher blinding, the allocation treatment order will be performed by an independent third party who will not take further part in the study. Allocation to conditions will be performed via computer, randomly assigning each participant to a treatment order.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21901 0
New Zealand
State/province [1] 21901 0
Auckland

Funding & Sponsors
Funding source category [1] 303974 0
Commercial sector/Industry
Name [1] 303974 0
Douglas Pharmaceuticals Ltd
Address [1] 303974 0
2 Te Pai Pl
Henderson
Auckland 0610
Country [1] 303974 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
Auckland (Oteha Rohe)
Albany Highway
Albany 0632
Country
New Zealand
Secondary sponsor category [1] 304146 0
None
Name [1] 304146 0
Address [1] 304146 0
Country [1] 304146 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304474 0
Health and Disability Ethics Committee (HDEC)
Ethics committee address [1] 304474 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 304474 0
New Zealand
Date submitted for ethics approval [1] 304474 0
06/09/2019
Approval date [1] 304474 0
08/10/2019
Ethics approval number [1] 304474 0
19/CEN/157

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97074 0
A/Prof Pamela von Hurst
Address 97074 0
Massey University
Auckland (Oteha Rohe)
Albany Highway
Albany 0632
Country 97074 0
New Zealand
Phone 97074 0
+64 9 4140800 43657
Fax 97074 0
Email 97074 0
h.mazahery@massey.ac.nz
Contact person for public queries
Name 97075 0
Dr Hajar Mazahery
Address 97075 0
Massey University
Auckland (Oteha Rohe)
Albany Highway
Albany 0632
Country 97075 0
New Zealand
Phone 97075 0
+64 2 2687 2997
Fax 97075 0
Email 97075 0
h.mazahery@massey.ac.nz
Contact person for scientific queries
Name 97076 0
Dr Hajar Mazahery
Address 97076 0
Massey University
Auckland (Oteha Rohe)
Albany Highway
Albany 0632
Country 97076 0
New Zealand
Phone 97076 0
+64 02 2687 2997
Fax 97076 0
Email 97076 0
h.mazahery@massey.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results