None listed
Conditions
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.
Interventions
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
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.
Sponsors
Clinical Research Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
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
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
Outcome results
None listed