ACTRN12610000849099
Completed
Phase 3
A study of the acute cognitive and neurocognitive effects of Panax Quinquefolius in healthy middle aged volunteers.
aturex0 sites50 target enrollmentOctober 8, 2010
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Cognitive Function
- Sponsor
- aturex
- Enrollment
- 50
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Healthy non\-smoking males and females aged between 40 and 60 years.
- •2\. No history of anxiety, depression, psychiatric disorders confirmed using Depression Anxiety Stress Scale) or epilepsy
- •3\. No history of / do not currently suffer from heart disease or high blood pressure or diabetes
- •4\. Not taking any medication, herbal extracts, vitamin supplements or illicit drugs for 4 weeks prior to (and duration of) study
- •5\. Not taking any form of medication within 5 days of admission (except for prophylactic antibiotics, or other routine medications to treat benign conditions, such as antibiotics to treat acne) and agree not to take any medication throughout the study
- •6\. No health conditions that would affect food metabolism including the following: food allergies, kidney disease, liver disease and/or gastrointestinal diseases (e.g. Irritable bowel syndrome, coeliac disease, peptic ulcers)
- •7\. Absence of pregnancy (confirmed using a pregnancy test)
- •8\. Are willing and able to participate in all scheduled visits, treatment plan, tests and other trial procedures according to the protocol
- •9\. Are willing to provide small finger prick blood samples throughout the testing phases
- •10\. Are not photosensitive (a sensitivity to visual stimuli, such as flashing lights, bright lights, light presented to full visual field, or static or moving patterns of light and dark stripes)
Exclusion Criteria
- •Smoker, hypersensitivity to investigational product, anxiety, depression, psychiatric disorder, epilepsy, heart disease, high blood pressure, diabetes, taking medications, health conditions that would effect food metabolism, pregnant/breast feeding, unable to commit to testing days, photo sensitive, not willing to provide finger prick blood samples, use of over the counter herbal supplements and dietary supplements 4 weeks prior to the study, history of head injury/stroke, alcoholism, clinically relevant abnormalities in medical history.
Outcomes
Primary Outcomes
Not specified
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