Echinacea for the treatment of anxiety and stress in adults

Not Applicable

Completed

• Conditions: Anxiety; Mental Health - Anxiety

• Registration Number: ACTRN12620000212954
• Lead Sponsor: Clinical Research Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-21
• Study Completion: 2020-07-30
• Last Update Posted: 16 February 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in anxiety/stress as assessed by the Clinically Useful Anxiety Outcome Scale (CUXOS) total score.[Weeks 0, 1, 2, 4, 6 (primary timepoint)]

Secondary Outcome Measures

Name	Time	Method
Change in quality of life as measured by the Short Form -36.[Weeks 0, 2, 4, 6 ];Change in sleep quality as measured by the Bergen Insomnia Scale (BIS).[Weeks 0, 2, 4, 6];Change in mood as measured by the Positive and Negative Affect Schedule (PANAS).[Weeks 0, 1, 2, 4, 6];Change in anxiety/stress as assessed by the Clinically Useful Anxiety Outcome Scale (CUXOS) psychic anxiety sub-scale score.[Weeks 0, 1, 2, 4, 6];Change in anxiety/stress as assessed by the Clinically Useful Anxiety Outcome Scale (CUXOS) somatic anxiety sub-scale score.[Weeks 0, 1, 2, 4, 6]