None listed
Conditions
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 2 weeks. We will assess changes in anxiety using the State-Trait Anxiety Inventory and general wellbeing using the World Health Organisation (WHO) - 5 Wellbeing Index which will be administered at regular times before, during, and 1 week after tablet intake.
Interventions
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.
Sponsors
Clinical Research Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed