Category
»
Primary study
Registry of Trials»ANZCTR
Year
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2020
INTERVENTION: 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 (EP107â„¢) – (2 tablets twice daily, delivering 40mg of Echinacea angustifolia daily) Condition 3: Echinacea angustifolia extract (EP107â„¢) – (2 tablets twice daily, delivering 80mg of Echinacea angustifolia daily) Adherence to tablet intake will be monitored through tablet return and count. CONDITION: Anxiety; ; Anxiety Mental Health ‐ Anxiety PRIMARY OUTCOME: 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: 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] Change in mood as measured by the Positive and Negative Affect Schedule (PANAS).[Weeks 0, 1, 2, 4, 6] 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] 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
Epistemonikos ID: 2329647a4ac570f1fceab5ae3765c20d068cf614
First added on: Aug 24, 2024