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Trial registered on ANZCTR


Registration number
ACTRN12620000212954
Ethics application status
Approved
Date submitted
14/02/2020
Date registered
21/02/2020
Date last updated
27/05/2020
Date data sharing statement initially provided
21/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Echinacea for the treatment of anxiety and stress in adults
Scientific title
An investigation into the anxiety- and stress-relieving effects of Echinacea angustifolia (EP107™): a randomised, double-blind, placebo-controlled study
Secondary ID [1] 300504 0
None
Universal Trial Number (UTN)
U1111-1248-3174
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 316192 0
Condition category
Condition code
Mental Health 314484 314484 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Adult participants aged between 18 and 65 years and experiencing high stress will be randomly allocated to one of 3 treatment conditions for 6 weeks comprising:

Condition 1: Placebo tablets (2 tablets twice daily)

Condition 2: Echinacea angustifolia extract (EP107™) – (2 tablets twice daily, delivering 40mg of Echinacea angustifolia daily)

Condition 3: Echinacea angustifolia extract (EP107™) – (2 tablets twice daily, delivering 80mg of Echinacea angustifolia daily)

Adherence to tablet intake will be monitored through tablet return and count.
Intervention code [1] 316823 0
Treatment: Drugs
Comparator / control treatment
Placebo (containing cellulose or rice powder) is matched to the Echinacea angustifolia tablets in terms of taste and appearance but does not contain any of the active ingredients.
Control group
Placebo

Outcomes
Primary outcome [1] 322828 0
Change in anxiety/stress as assessed by the Clinically Useful Anxiety Outcome Scale (CUXOS) total score.
Timepoint [1] 322828 0
Weeks 0, 1, 2, 4, 6 (primary timepoint)
Secondary outcome [1] 379920 0
Change in quality of life as measured by the Short Form -36.
Timepoint [1] 379920 0
Weeks 0, 2, 4, 6
Secondary outcome [2] 379921 0
Change in sleep quality as measured by the Bergen Insomnia Scale (BIS).
Timepoint [2] 379921 0
Weeks 0, 2, 4, 6
Secondary outcome [3] 379922 0
Change in mood as measured by the Positive and Negative Affect Schedule (PANAS).
Timepoint [3] 379922 0
Weeks 0, 1, 2, 4, 6
Secondary outcome [4] 380135 0
Change in anxiety/stress as assessed by the Clinically Useful Anxiety Outcome Scale (CUXOS) psychic anxiety sub-scale score.
Timepoint [4] 380135 0
Weeks 0, 1, 2, 4, 6
Secondary outcome [5] 380136 0
Change in anxiety/stress as assessed by the Clinically Useful Anxiety Outcome Scale (CUXOS) somatic anxiety sub-scale score.
Timepoint [5] 380136 0
Weeks 0, 1, 2, 4, 6

Eligibility
Key inclusion criteria
1. Healthy adults (male and female) between 18 and 65
2. Experiencing mild-to-moderate severity of stress/anxiety (score between 11 and 40 on the CUXOS)
3. Stressor/anxiety has been present for greater than a month
4. Medication-free for at least 3 months. Use of analgesics (once a week) or contraceptive pill are permissible.
5. Non-smoker
6. BMI between 20 and 35
7. No plan to commence new treatments over study period
8. Willing to provide a personally signed informed consent form detailing all pertinent aspects of the trial.
9. Willing and able to take prescribed tablets for 6 weeks
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Alcohol consumption > 14 standard drinks per week
2. Current or 12-month history of illicit drug abuse
3. Pregnant women, women who are breastfeeding or women who intended to fall pregnant.
4. Suffering from medical conditions including but not limited to: gastrointestinal disease, functional gastrointestinal disorder, diabetes, hyper/hypotension, cardiovascular disease, gallbladder disease/gallstones/biliary disease, endocrine disease, psychiatric disorder (other than mild-to-moderate anxiety), and neurological disease (Parkinson’s, Alzheimer’s disease, intracranial haemorrhage, head or brain injury)
5. Currently taking supplements that may impact on treatment outcome

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)
Participants will be randomly and equally assigned to three groups (high-dose Echinacea, low-dose Echinacea, and placebo). These groups are named group 1, group 2, and group 3, respectively. The research investigators and participants will be unaware of which treatment these groups represent. This computer-generated randomisation structure will comprise 7 randomly permuted blocks, containing 15 participants per block. Participant identification number (1 to 105) will be allocated according to the order of participant enrolment in the study. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation calculator (http://www.randomization.com).
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
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Based on a previous study on echinacea, we are predicting an effect size of 0.7 compared to placebo. Based on this, a sample size of 26 is required. This gives an 80% chance of finding an effect at a statistical significance of 0.05. In this study, we will be recruiting 35 participants per group (105 participants in total), which should give us a suitable power to find an effect, even after dropouts.

Pre and post analyses will be conducted to determine changes in the following:
1. Clinically Useful Anxiety Outcome Scale (CUXOS) (total and subscale scores psychic anxiety and somatic anxiety
2. Short Form -36 (SF-36) subscale scores
3. Bergen Insomnia Scale (BIS).
4. Positive and Negative Affect Schedule (PANAS)

Recruitment
Recruitment status
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 in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC

Funding & Sponsors
Funding source category [1] 304921 0
Commercial sector/Industry
Name [1] 304921 0
EuroPharma Inc
Address [1] 304921 0
955 Challenger Dr. Green Bay, WI 54311
Country [1] 304921 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Clinical Research Australia
Address
38 Arnisdale Rd Duncraig WA 6023
Country
Australia
Secondary sponsor category [1] 305269 0
None
Name [1] 305269 0
Address [1] 305269 0
Country [1] 305269 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305329 0
National Institute of Integrative Medicine (NIIM)
Ethics committee address [1] 305329 0
21 Burwood Rd
Hawthorn VIC 3122
Ethics committee country [1] 305329 0
Australia
Date submitted for ethics approval [1] 305329 0
10/12/2019
Approval date [1] 305329 0
13/02/2020
Ethics approval number [1] 305329 0
0061E_2019

Summary
Brief summary
In this randomised, double-blind, placebo-controlled study, 105 adults experiencing mild-to-moderate anxiety/stress will be randomly assigned to receive tablets containing a daily dose of either Echinacea angustifolia (40mg) (LOW DOSE), Echinacea angustifolia (80mg) (HIGH DOSE), or placebo for 6 weeks. We will assess changes in symptoms through the completion of validated questionnaires assessing anxiety, mood, quality of life, and sleep.
Trial website
https://clinicalresearch.com.au/cra-studies/echinacea-study/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100018 0
Dr Adrian Lopresti
Address 100018 0
Clinical Research Australia
38 Arnisdale Rd
Duncraig WA 6023
Country 100018 0
Australia
Phone 100018 0
+61894487376
Fax 100018 0
+61894478217
Email 100018 0
adrian@clinicalresearch.com.au
Contact person for public queries
Name 100019 0
Dr Adrian Lopresti
Address 100019 0
Clinical Research Australia
38 Arnisdale Rd
Duncraig WA 6023
Country 100019 0
Australia
Phone 100019 0
+61894487376
Fax 100019 0
+61894478217
Email 100019 0
adrian@clinicalresearch.com.au
Contact person for scientific queries
Name 100020 0
Dr Adrian Lopresti
Address 100020 0
Clinical Research Australia
38 Arnisdale Rd
Duncraig WA 6023
Country 100020 0
Australia
Phone 100020 0
+61894487376
Fax 100020 0
+61894478217
Email 100020 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 by emailing the principal investigator adrian@clinicalresearch.com.au
What supporting documents are/will be available?
No other documents available
Summary results
No Results