A further examination of the short-term anxiolytic effects of an Echinacea extract (EP107)in adults experiencing increased anxiety

Not Applicable

Recruiting

• Conditions: Anxiety; Sleep disturbance; Alternative and Complementary Medicine - Herbal remedies; Mental Health - Anxiety; Mental Health - Other mental health disorders

• Registration Number: ACTRN12623001231639
• Lead Sponsor: Clinical Research Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-11-30
• Last Update Posted: 29 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified