An examination of the short-term anxiolytic effects of an Echinacea extract (Anxiofit-1/EP107) in adults experiencing anxiety

Not Applicable

Completed

• Conditions: Anxiety; Mental Health - Anxiety

• Registration Number: ACTRN12622000798763
• Lead Sponsor: Clinical Research Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-06-07
• Study Completion: 2022-12-16
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 82

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
State-Trait Anxiety Inventory (STAI) - State Score[Days 7 & 3 pre-intervention commencement; and days 0, 3, 7, 14 (primary endpoint), and 21 post-intervention commencement]

Secondary Outcome Measures

Name	Time	Method
State-Trait Anxiety Inventory (STAI) - Trait Score[Days 7 & 3 pre-intervention commencement; and days 0, 3, 7, 14, and 21 post-intervention commencement];World Health Organization (WHO) - 5 Wellbeing Index [Days 0, 7, 14, and 21 post-intervention commencement]