Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001231639
Ethics application status
Approved
Date submitted
4/11/2023
Date registered
30/11/2023
Date last updated
19/01/2024
Date data sharing statement initially provided
30/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A further examination of the short-term anxiolytic effects of an Echinacea extract (EP107)
in adults experiencing increased anxiety
Scientific title
A further examination of the short-term anxiolytic effects of an Echinacea extract (EP107)
in adults experiencing increased anxiety: A randomised, double-blind, placebo-controlled
trial
Secondary ID [1] 310874 0
None
Universal Trial Number (UTN)
U1111-1299-9238
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 331920 0
Sleep disturbance 331921 0
Condition category
Condition code
Alternative and Complementary Medicine 328651 328651 0 0
Herbal remedies
Mental Health 328652 328652 0 0
Anxiety
Mental Health 328792 328792 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Echinacea extract (EP107) (2 tablets taken orally, twice daily, with or without food, delivering 80 mg a day for 7 days). Adherence to tablet intake will be measured by a tablet count by participants at day 7.
Intervention code [1] 327299 0
Treatment: Other
Comparator / control treatment
A matching placebo (containing cellactose) in terms of taste and appearance and containing all ingredients except the active ingredient (Echinacea extract)
Control group
Placebo

Outcomes
Primary outcome [1] 336450 0
Anxiety (state)
Timepoint [1] 336450 0
Day 0 (pre-commencement of intervention), day 3 and day 7 post-intervention commencement (day 7 as the primay endpoint), and 2 weeks after stopping tablet intake.
Secondary outcome [1] 428541 0
Anxiety (Trait)
Timepoint [1] 428541 0
Day 0 (pre-commencement of intervention), day 3 and day 7 post-intervention commencement, and 2 weeks after stopping tablet intake.
Secondary outcome [2] 428542 0
Sleep
Timepoint [2] 428542 0
Day 0 (pre-commencement of intervention), day 7 post-intervention commencement, and 2 weeks after stopping tablet intake.

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 both the State-Trait Anxiety Inventory (STAI), State and Trait Subscale Scores at both screening and baseline
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 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, breastfeeding 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)
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 computer software
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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/12/2023
Actual
6/12/2023
Date of last participant enrolment
Anticipated
12/02/2024
Actual
Date of last data collection
Anticipated
4/03/2024
Actual
Sample size
Target
80
Accrual to date
6
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 315135 0
Commercial sector/Industry
Name [1] 315135 0
Anxiofit Ltd,
Country [1] 315135 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] 317152 0
None
Name [1] 317152 0
Address [1] 317152 0
Country [1] 317152 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314073 0
National Institute of Integrative Medicine (NIIM) Human Research Ethics Committee
Ethics committee address [1] 314073 0
11-23 Burwood Rd Hawthorn VIC 3122
Ethics committee country [1] 314073 0
Australia
Date submitted for ethics approval [1] 314073 0
01/09/2023
Approval date [1] 314073 0
09/11/2023
Ethics approval number [1] 314073 0
0129E_2023

Summary
Brief summary
In this randomised, double-blind, placebo-controlled study, 80 adults experiencing anxiety will be randomly assigned to receive tablets containing either an echinacea extract (EP107) (40mg twice daily) or a placebo for 7 days. We will assess changes in anxiety using the State-Trait Anxiety Inventory and sleep quality using the PROMIS Sleep Disturbance and Sleep-Related Impairment Scale. These questionnaires will be administered at regular times before, during, and 2 weeks after stopping tablet intake.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130310 0
Dr Adrian Lopresti
Address 130310 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 130310 0
Australia
Phone 130310 0
+61 8 94487376
Fax 130310 0
Email 130310 0
adrian@clinicalresearch.com.au
Contact person for public queries
Name 130311 0
Dr Adrian Lopresti
Address 130311 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 130311 0
Australia
Phone 130311 0
+61 8 94487376
Fax 130311 0
Email 130311 0
adrian@clinicalresearch.com.au
Contact person for scientific queries
Name 130312 0
Dr Adrian Lopresti
Address 130312 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 130312 0
Australia
Phone 130312 0
+61 8 94487376
Fax 130312 0
Email 130312 0
adrian@clinicalresearch.com.au

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 (adrian@clinicalresearch.com.au)


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
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