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 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.
Interventions
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.
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 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.
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.
Outcome results
None listed