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

Phase 2

Recruiting

• Conditions: Dizziness; Vertigo; Meniere's disease; Neurological - Other neurological disorders; Ear - Other ear disorders

• Registration Number: ACTRN12624000037505
• Lead Sponsor: Southern Cross University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-17
• Last Update Posted: 21 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 160

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

Exclusion Criteria

Medical history
-Current, clinically significant acute disease
-Indicators of an unmanaged and clinically significant chronic disease (as per participant self-reporting and investigator review)
-History of a physical head injury that has current, clinically significant sequela
-History of a CVA (stroke) or TIA (mini-stroke) or brain injury that has been diagnosed as the cause of the dizziness/vertigo symptoms
-A diagnosis of diabetes, pre-diabetes or insulin resistance
-Diagnosed bleeding disorder
-Clinically significant history of epistaxis (nose bleeds) that requires medical intervention to achieve haemostasis
-Recent (in the last 3 months) surgery on the eyes, brain or spinal cord
-Planned surgery during the 12 weeks of the trial
-Current stomach ulcer(s) or symptoms of stomach ulcers (e.g. gastritis) or currently taking medication (regular or PRN) to treat/prevent a stomach ulcer
-Any clinical indicators of current, clinically significant dehydration (e.g. oliguria, chronic thirst)
-Unstable or newly diagnosed (in last 3 months) cardiac condition
-Any current condition characterised by severe diarrhoea, severe constipation, excessive sweating or dry cough
-Any condition where the maintenance of fluid balance is important (e.g. may include certain cardiac or kidney conditions. Such conditions may be indicated by the use of potassium or other electrolytes supplements)
-Known history of hypotension (less than 90 systolic or greater than 60 diastolic) or uncontrolled hypertension (as per participant self-reporting)

Mental health and related conditions
-Diagnosed, severe mental illness (e.g. by a psychiatrist)
-Severe cognitive impairment e.g. dementia

Lifestyle
-Current or recent (in last 28 days) alcoholism (>14 standard drinks per week) or current or recent (in last 28 days) recreational drug use

Medications
-Current or foreseeable use of nasal sprays during the trial
-Current use of diabetic medication
-Current use of prescription diuretics (supplements with diuretic action are permissible)
-Current use of any prescription anti-coagulant or anti-platelet medicine including regular aspirin (PRN use of aspirin is permissible)
-Current use (regular or PRN) of pentobarbital
-Current use (regular or PRN) of any benzodiazepine medication
-Concurrent use of any supplement/medication containing any of the ingredients in the IMP

Other
-Those who are pregnant or breast-feeding
-Unwilling to use contraception throughout the trial
-Concurrent use of any supplement/medication with a known interaction with any IMP ingredient
-Known allergy or intolerance to any of the ingredients in the IMP

Pathology abnormalities
- Screening pathology testing indicative of clinically significant potassium or sodium below the LLN
-Screening pathology testing indicative of clinically significant abnormal fasted glucose and/or HbA1c
-Screening pathology testing indicative of clinically significant anaemia (e.g. Red blood count, haematocrit or haemoglobin significantly below the LLN) or thrombocytopenia (platelets significantly below LLN)
-Screening pathology indicative of clinically significant abnormal clotting (e.g. prothrombin time (PT) significantly outside normal limits)
-Screening pathology testing of 25-hydroxy-vitamin D less than or equal to 30 nmol/L

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)]