Nutritional and botanical support for fatigue in burnout: A randomised controlled pilot and feasibility study

INTERVENTION: The intervention consists of one botanical and nutritional preparation (2 capsules AM) and one nutritional supplement (1 scoop powder PM) or their active controls. Duration 8 weeks. Give Back Health RejuveGen AUST L 396075. Oral hard capsule (size OOel vegecap) with grey‐green powder. Dose is two capsules every morning. Each capsule contains Astragalus membranaceus root 200 mg (Equivalent Astragalus membranaceus (Dry) 2 g); Bacopa monnieri whole plant 200 mg (Equivalent: Bacopa monnieri (Dry) 4 g); nicotinamide riboside chloride 50 mg (Equivalent: ribose 25.82 mg); Pana Xginseng root 100 mg (Equivalent: Pana Xginseng (Dry) 400 mg); quercetin dihydrate 125 mg; Scutellaria baicalensis root 100 mg (Equivalent: Scutellaria baicalensis (Dry) 2 g). Give Back Health MagRela XAUST L 375975. Oral powder (white) where dose is one scoop of a powder (5.3 g) per day which contains 350 mg of magnesium as magnesium citrate plus 3.0 grams L‐glycine. Mi Xone included scoop (5.3 gram) with water and consume immediately. Take 30 mins before bed. Adherence to the intervention will be monitored by return of all supplement bottles/containers at each clinic visit. CONDITION: Alternative and Complementary Medicine ‐ Other alternative and complementary medicine Burnout; ; Burnout Mental Health ‐ Other mental health disorders PRIMARY OUTCOME: Feasibility as a composite of three measures[Feasibily will be assessed as a composite of: i) the ability to recruit sufficient numbers of eligible participants; ii) the timely completion of the supplements; iii) the acceptability of the interventions to the participants and the success of blinding of group allocation i) Data will be collected and reported on the numbers of applicants through the whole screening, enrolling and consenting processes; ii) Compliance with the protocol will be checked through collecting and counting discarded products after the bottle exchanges at Study Clinic 2 (Week 4) and Study Clinic 3 (Week 8). iii) At the end of the supplementation phase clinic interview in Week 8. ] Safety of the interventions as a composite of two measures.[Safety of the interventions will be measured as a composite of: i) blood tests (full blood count (FBC), urea, electrolytes creatinine (UEC), and liver function test (LFT); and ii) adverse events monitoring. i) Blood tests will be taken within 72 hours after Baseline and within 72 hours after completion of supplements in Week 8; ii) Participants will also be encouraged to report any untoward event directly to the Clinical Trial Co‐ordinator or the Chief Investigator. All adverse events associated with this study will be recorded and reported in the Client Report Form. During the trial, any adverse event that may have occured will also be recorded at Study Clinic 2 (Week 4), Study Clinic 3 (Week 8) and follow up (Week 10). ] SECONDARY OUTCOME: Burnout (composite)[The total score of the Sydney Burnout Measure (SBM) will be used. Baseline, week 4, week 8 after commencement of the interventions, and follow‐up at week 10.] Fatigue[Fatigue Severity Scale (FSS) Baseline, week 4, week 8 after commencement of the interventions, and follow‐up at week 10.] Mental wellbeing[Warwick‐Edinburgh Mental Well‐being Scale (WEMWBS). Baseline, week 4, week 8 after commencement of the interventions, and follow‐up at week 10.] Patient reported outcomes[Patient Specific Scale (PSS) Baseline, week 4, week 8 after commencement of the interventions, and follow‐up at week 10.] Stress[Perceived Stress Scale (PSS‐10) Baseline, week 4, week 8 after commencement of the interventions, and follow‐up at week 10.] INCLUSION CRITERIA: • Currently experiencing burnout, as indicated by a score of 50 or higher on the Sydney Burnout Measure (SBM) • Read, speak, and understand the English language • Have access to the internet on a computer or smartphone • Otherwise healthy