Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000798763
Ethics application status
Approved
Date submitted
1/06/2022
Date registered
7/06/2022
Date last updated
14/02/2023
Date data sharing statement initially provided
7/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
An examination of the short-term anxiolytic effects of an Echinacea extract (Anxiofit-1/EP107) in adults experiencing anxiety
Scientific title
An examination of the short-term anxiolytic effects of an Echinacea extract (Anxiofit-1/EP107) in adults experiencing increased anxiety: A randomised, double-blind, placebo-controlled trial
Secondary ID [1] 307268 0
None
Universal Trial Number (UTN)
U1111-1278-8762
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 326522 0
Condition category
Condition code
Mental Health 323787 323787 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Echinacea angustifolia extract (EP107) (2 tablets taken orally, twice daily with or without food, delivering 80mg a day for 14 days). Adherence to tablet intake will be measured by a pill count by the participant at the end of the study.
Intervention code [1] 323707 0
Treatment: Other
Comparator / control treatment
Placebo (containing alpha-lactose monohydrate and cellulose) is matched to the echinacea extract tablets in terms of taste and appearance but does not contain any of the active ingredients.
.
Control group
Placebo

Outcomes
Primary outcome [1] 331560 0
State-Trait Anxiety Inventory (STAI) - State Score
Timepoint [1] 331560 0
Days 7 & 3 pre-intervention commencement; and days 0, 3, 7, 14 (primary endpoint), and 21 post-intervention commencement
Secondary outcome [1] 410294 0
State-Trait Anxiety Inventory (STAI) - Trait Score
Timepoint [1] 410294 0
Days 7 & 3 pre-intervention commencement; and days 0, 3, 7, 14, and 21 post-intervention commencement
Secondary outcome [2] 410295 0
World Health Organization (WHO) - 5 Wellbeing Index
Timepoint [2] 410295 0
Days 0, 7, 14, and 21 post-intervention commencement

Eligibility
Key inclusion criteria
1. Generally, healthy adults (male and female) aged 18 to 80 years
2. Currently self-reporting experiencing high stress and/or anxiety
3. A score of 45 or higher on the STAI-state subscale
4. Non-smoker
5. BMI between 18 and 30 kg/m2
6. No plan to commence new treatments over the study period
7. Understand, willing and able to comply with all study procedures
8. Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Currently receiving, or in the previous 3 months, psychological intervention for anxiety or depression.
2. Diagnosis of psychiatric or neurological conditions including but not limited to: any psychiatric disorder, or neurological disease (Parkinson’s, Alzheimer’s disease, intracranial haemorrhage, head or brain injury)
3. Suffering from recently diagnosed or unmanaged medical conditions including but not limited to: diabetes, hyper/hypotension, cardiovascular disease, gastrointestinal disease requiring regular use of medications, gallbladder disease, autoimmune disease, endocrine disease, acute or chronic pain condition, or cancer/malignancy
4. Regular medication intake including but not limited to anticholinergics, anti-epileptics, antihistamines, benzodiazepines, opioids, or corticosteroids.
5. Change in medication in the last 3 months or expectation to change during the study duration
6. In the last 6 months, commenced or changed dose of nutritional and/or herbal supplements that may impact on treatment outcome
7. Current or 12-month history of illicit drug abuse
8. Alcohol intake greater than 14 standard drinks per week
9. Participation in any other clinical trial in the last 3 months
10. Any significant surgeries over the last year
11. Overnight shift workers
12. Pregnant, breast-feeding or women who plan to fall pregnant 3 months after the end of the study.
13. Planned major lifestyle change in the next 2 months
14. Known allergy to Echinacea, chamomile or sunflower oil.

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)
Allocation is concealed through the use of numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation using a randomisation table created by a computer software. This computer-generated randomisation structure will comprise 8 randomly permuted blocks, containing 10 participants per block.
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on previous studies on echinacea, we are predicting an effect size of 0.6 compared to the placebo. Based on this, a sample size of 36 per group is required. This gives an 80% chance of finding an effect at a statistical significance of 0.05. We will be recruiting 40 participants per group (80 participants in total). Based on the 80 people recruited, we have a suitable power to find an effect, even after dropouts.

Generalised Linear Mixed Models (GLMM) will be used to assess for differences between intervention groups on primary and secondary outcomes over time, with intervention effects assessed via entry of intervention group (placebo and Echinacea) x time interaction.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/07/2022
Actual
19/09/2022
Date of last participant enrolment
Anticipated
1/12/2022
Actual
25/11/2022
Date of last data collection
Anticipated
22/12/2022
Actual
16/12/2022
Sample size
Target
80
Accrual to date
Final
82
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC

Funding & Sponsors
Funding source category [1] 311565 0
Commercial sector/Industry
Name [1] 311565 0
Anxiofit Ltd,
Country [1] 311565 0
Hungary
Primary sponsor type
Commercial sector/Industry
Name
Clinical Research Australia
Address
38 Arnisdale Rd Duncraig WA 6023
Country
Australia
Secondary sponsor category [1] 312981 0
None
Name [1] 312981 0
Address [1] 312981 0
Country [1] 312981 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311013 0
National Institute of Integrative Medicine (NIIM) Human Research Ethics Committee
Ethics committee address [1] 311013 0
Ethics committee country [1] 311013 0
Australia
Date submitted for ethics approval [1] 311013 0
16/05/2022
Approval date [1] 311013 0
20/06/2022
Ethics approval number [1] 311013 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119698 0
Dr Adrian Lopresti
Address 119698 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 119698 0
Australia
Phone 119698 0
+61 08 9448 7376
Fax 119698 0
Email 119698 0
[email protected]
Contact person for public queries
Name 119699 0
Adrian Lopresti
Address 119699 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 119699 0
Australia
Phone 119699 0
+61 08 9448 7376
Fax 119699 0
Email 119699 0
[email protected]
Contact person for scientific queries
Name 119700 0
Adrian Lopresti
Address 119700 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 119700 0
Australia
Phone 119700 0
+61 08 9448 7376
Fax 119700 0
Email 119700 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
for IPD meta-analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected])


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.