None listed
Conditions
Brief summary
The aim of testing this product to ensure its safety and dose before commencing a clinical trial for efficacy in participants experiencing dizziness and vertigo. The trial will enroll 20 healthy volunteers who will receive either 4 tablets a day or 4 tablets twice a day for 15 days and then have 15 days without the tablet to monitor for safety.
Interventions
Two capsules twice daily taken 4 hours apart containing Nelumbinis folium(3,000mg), Alismatis Rhizoma (25,000mg), Citri reticulatae Pericarpium (3000mg), Citri reticulatae viride Pericarpium (3,000mg), Atractylodis macrocephalae Rhizoma (10,000mg).
The mode will be an oral capsule taken daily for 15 days and compliance will be monitored by capsule return and a diary.
Sponsors
Southern Cross University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy adults aged between 18 and 60 years old 2. BMI is equal or greater than 18.5 and below 35
Exclusion criteria
1. Pregnant or breast-feeding women or those unwilling to use effective contraception during the trial 2. Anyone with an acute disease 3. Weak or emancipated people 4. Indicators of an unmanaged chronic disease as judged by the health qualified researcher before enrolment. 5. Unable to speak or understand English or cannot understand the trial 6. Severe mental illness or difficulty communicating 7. Current alcoholism ( >14 standard drinks a week) or current recreational drug use 8. Current use of diabetic medication 9. A diagnosis of diabetes mellitus (any type) 10. Current bleeding disorder 11. Current stomach ulcer(s) or current medication to treat/prevent stomach ulcers 12. Anyone who experiences migraine, vertigo and/or dizziness from a physical injury or a brain tumour 13. People with dry cracked lips (from a TCM perspective) 14. Current use of diuretics (prescription of supplement) 15. Any condition characterised by severe diarrhoea. 16. Current severe constipation 17. Currently experiencing excessive sweating episodes 18. Current dry cough 19. Concurrent use of any medication/supplement with a known interaction with any IMP ingredient 20. Known allergy or intolerance to any of the ingredients in the IMP
Outcome results
None listed