None listed
Conditions
Brief summary
This study seeks to establish a reference range for a urinary kryptopyrrole test produced and conducted by SAFE Analytical Laboratories Pty Ltd ("the test"), This study is aiming to provide suitable data to enable registration of the test on the Australian Register of Therapeutic Goods (ARTG). Four parts to this study have been designed to correlate the urinary kryptopyrrole levels with health and disease states as observed in adult populations.
Interventions
This a 4 arm study seeking to validate an in-vitro diagnostic medical device. It requires retrospective observational data from clinicians in the form of a survey, prospective data from healthy adults and adults with a specific condition through concurrent clinical trial, and prospective case report data from clinicians using urinary kryptopyrrole testing which will also be collected concurrently. The first arm (a survey) guides disease selection for arm 3 (observational study). The results of arm 2, 3 and 4, once completed, will be correlated to see any difference between healthy adults and those diagnosed with different diseases. Arm 2: An observational study of healthy adults. Participants will provide a urine sample on which urinary kryptopyrrole analysis will be performed at baseline, week 1 and week 2 (3 urine samples). Participants will also fill out a questionnaire (the Depression Anxiety Stress Scales 21 (DASS-21)), which will be used for correlation with the urine analysis. Arm 3: An observational study of people diagnosed with anxiety. Participants will provide a urine sample on which urinary kryptopyrrole analysis will be performed at baseline, week 1 and week 2 (3 urine samples). Participants will also fill out two questionnaires (the Depression Anxiety Stress Scales 21 (DASS-21)) and the GAD-7, which will be both compared to each other, and used for correlation with the urine analysis. Arm 4: An observational case-control study where clinicians will recruit their patients into this study for baseline and follow-up visits. Clinical practice will commence as normal (including urinary kryptopyrrole [UKP]sampling), but the DASS-21 questionnaire will be added. Case management data will be collected by the research team and analysed for signficance compared to the UKP level, plus correlation between UKP level, disease outcome, and DASS-21 scores.
Sponsors
Eligibility
Inclusion criteria
Arm 2 * Healthy adults aged 18 or more years * No current diagnosed health conditions * Not currently pregnant or breastfeeding Arm 3 * Adults aged 18 or more years * Diagnosed with anxiety. * Not currently pregnant or breastfeeding
Exclusion criteria
Any currently diagnosed health condition. Pregnant and/or breastfeeding.