A Phase IIb trial assessing a Chinese Medicine for Dizziness and Vertigo.

INTERVENTION: A Chinese herbal mi Xthat contains Alismatis Rhizoma 25,000mg, Atractylodes macrocephalia rhizoma 10,000mg, Citri reticulatae Pericarpium peel 3,000mg, Citri reticulatae viride Pericarpium peel 3,000mg and Nelumbinis folium leaf 3,000mg in a capsule. The dose administered is 2 capsules taken once daily. for 14 days initially. After 28 days, if the participant has a dizziness episode, they are able to take the IMP for 7 days for 2 dizziness episode. The participant is enrolled in the trial for 12 weeks; The mode of administration is an oral capsule Adherence to the IMP is via capsule return CONDITION: Dizziness;Vertigo;Meniere's disease; ; Dizziness ; Vertigo ; Meniere's disease Ear ‐ Other ear disorders Neurological ‐ Other neurological disorders PRIMARY OUTCOME: Frequency of symptoms [Vertigo Symptoms Scale (VSS‐0sf) Baseline compared to 12 weeks post commencement of dosing (primary timepoint)] Severity of symptoms [Visual Analogue Scale Baseline compared to week 12 post‐commencement of dosing (primary outcome)] SECONDARY OUTCOME: Adverse Events[Side events recorded on the participant diary Baseline compared to 12 weeks post commencement of dosing (follow up visits at week 4, 8 and 12 post commencement of dosing)] Amount of rescue medication used [Days and number of times rescue medication was used recorded in a diary. Baseline compared to week 12 post commencement of dosing] Duration of each dizziness/vertigo episode [Minutes of each episode recorded in a participant diary on REDCap online link. Baseline compared to week 12 post commencement of dosing] Impact on activities of daily living (ADLs) [Dizziness Handicap Inventory (DHI) Baseline compared to week 12 compared to post‐commencement of IMP (follow‐ups conducted at week 4, 8 and 12 post commencement of dosing)] Impact on those participants with diagnosed Meniere’s disease [Meniere's Disease Patient‐Orientated Severity Inde Xversion 2 ((MDPOSI v2) Baseline compared to Week 12 post commencement of dosing (follow‐ups conducted at week 4, 8 and 12 post commencement of dosing)] Number of episodes of dizziness [Number of dizziness episodes they experience in a participant diary recorded on REDCap which is a online link. Baseline compared to week 12 post commencement of dosing] Quality of life[SF‐36 Baseline compared to week 12 post commencement of dosing (follow‐ups conducted at week 4, 8 and 12 post commencement of dosing)] Safety [Via blood pathology of liver enzymes Baseline compared to week 12 post commencement of dosing (follow‐ups conducted at week 4, 8 and 12 post commencement of dosing)] Safety[Via blood pathology of kidney function Baseline compared to week 12 post commencement of dosing (follow‐ups conducted at week 4, 8 and 12 post commencement of dosing)] Vertigo [Vestibular Rehabilitation Benefit Questionnaire (VRBQ) Baseline compared to week 12 post commencement of dosing (follow up visits on week 4, 8 and 12 post commencement of dosing)] INCLUSION CRITERIA: Have a diagnosed dizziness/vertigo condition for greater or equal to 3 months (e.g. Meniere’s disease) Experiences dizziness/vertigo symptoms greater or equal to once per month