Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000037505
Ethics application status
Approved
Date submitted
20/11/2023
Date registered
17/01/2024
Date last updated
15/05/2024
Date data sharing statement initially provided
17/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase IIb trial assessing a Chinese Medicine for Dizziness and Vertigo.
Scientific title
A Phase IIb Double-Blind Randomised Placebo-Controlled Trial assessing the efficacy of a Chinese Medicine formulation for Dizziness and Vertigo
Secondary ID [1] 310904 0
Nil known
Universal Trial Number (UTN)
Trial acronym
DIZZYTCM
Linked study record
This is a follow-on efficacy trial based on the safety trial ACTRN12623000765628 findings

Health condition
Health condition(s) or problem(s) studied:
Dizziness 331962 0
Vertigo 331963 0
Meniere's disease 331964 0
Condition category
Condition code
Neurological 328688 328688 0 0
Other neurological disorders
Ear 329069 329069 0 0
Other ear disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A Chinese herbal mix that 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
Intervention code [1] 327331 0
Treatment: Other
Intervention code [2] 327332 0
Prevention
Comparator / control treatment
Placebo is brown rice powder in a light beige capsule, the same as the invention.

Dose: 2 capsules for 14 days initially, After 28 days, If a participant has a dizzy episode, the are able to take the IMP for 7 days for 2 dizziness episodes.
The participant is enrolled in the trial for 12 weeks.
Mode of administration is an oral capsule..
The IMP adherance is being monitored by capsule return.
Control group
Placebo

Outcomes
Primary outcome [1] 336504 0
Frequency of symptoms
Timepoint [1] 336504 0
Baseline compared to 12 weeks post commencement of dosing (primary timepoint)
Primary outcome [2] 336505 0
Severity of symptoms
Timepoint [2] 336505 0
Baseline compared to week 12 post-commencement of dosing (primary outcome)
Secondary outcome [1] 428603 0
Impact on activities of daily living (ADLs)
Timepoint [1] 428603 0
Baseline compared to week 12 compared to post-commencement of IMP (follow-ups conducted at week 4, 8 and 12 post commencement of dosing)
Secondary outcome [2] 428604 0
Number of episodes of dizziness
Timepoint [2] 428604 0
Baseline compared to week 12 post commencement of dosing
Secondary outcome [3] 428605 0
Impact on those participants with diagnosed Meniere’s disease
Timepoint [3] 428605 0
Baseline compared to Week 12 post commencement of dosing (follow-ups conducted at week 4, 8 and 12 post commencement of dosing)
Secondary outcome [4] 428606 0
Duration of each dizziness/vertigo episode
Timepoint [4] 428606 0
Baseline compared to week 12 post commencement of dosing
Secondary outcome [5] 428607 0
Safety
Timepoint [5] 428607 0
Baseline compared to week 12 post commencement of dosing (follow-ups conducted at week 4, 8 and 12 post commencement of dosing)
Secondary outcome [6] 428608 0
Safety
Timepoint [6] 428608 0
Baseline compared to week 12 post commencement of dosing (follow-ups conducted at week 4, 8 and 12 post commencement of dosing)
Secondary outcome [7] 428609 0
Quality of life
Timepoint [7] 428609 0
Baseline compared to week 12 post commencement of dosing (follow-ups conducted at week 4, 8 and 12 post commencement of dosing)
Secondary outcome [8] 428610 0
Amount of rescue medication used
Timepoint [8] 428610 0
Baseline compared to week 12 post commencement of dosing
Secondary outcome [9] 429997 0
Adverse Events
Timepoint [9] 429997 0
Baseline compared to 12 weeks post commencement of dosing (follow up visits at week 4, 8 and 12 post commencement of dosing)
Secondary outcome [10] 429998 0
Vertigo
Timepoint [10] 429998 0
Baseline compared to week 12 post commencement of dosing (follow up visits on week 4, 8 and 12 post commencement of dosing)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The randomisation sequence will be generated via the online platform sealedenvelope.com.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation sequence will be a computer-generated random number based on block randomisation with varying block length ranging from 2 to 8. Two strata will be applied, i.e., sex,
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
All data will be analysed via SPSS 27.0. The analyses will be conducted on an intention-to-treat analysis, followed by a subsequent per-protocol analysis to examine the influence of compliance on the outcome measures. Missing data will be completed using the Markov chain Monte Carlo multiple imputation method in SPSS. A set of 50 imputations will be generated, and the mean score will be used for the ITT analyses.
The primary outcomes of total number of dizziness episodes and the VRBQ (total score) after 12 weeks will be compared between groups using univariate analysis (ANCOVA), which models the post-treatment outcome as a function of treatment group (classified factor), and the respective baseline value (linear covariate). Efficacy estimates will be reported as group differences with 95 percent confidence intervals, and effect sizes. A significance level of 2.5 percent will be applied for each of the two primary outcomes.
Secondary outcomes will be analysed using ANCOVA and paired T-test analysis. Adverse events will be described descriptively with numbers and percentages.
Associations between various outcomes will be analysed using correlational, and regression techniques.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/05/2024
Actual
Date of last participant enrolment
Anticipated
25/04/2025
Actual
Date of last data collection
Anticipated
24/10/2025
Actual
Sample size
Target
160
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 315163 0
Commercial sector/Industry
Name [1] 315163 0
CMOL Pharmaceutical Australia Pty Ltd
Country [1] 315163 0
Australia
Primary sponsor type
University
Name
Southern Cross University
Address
1 Military Road, Lismore, NSW 2480
Country
Australia
Secondary sponsor category [1] 317180 0
None
Name [1] 317180 0
Address [1] 317180 0
Country [1] 317180 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314097 0
Southern Cross University HREC
Ethics committee address [1] 314097 0
Ethics committee country [1] 314097 0
Australia
Date submitted for ethics approval [1] 314097 0
30/11/2023
Approval date [1] 314097 0
13/02/2024
Ethics approval number [1] 314097 0
2024/015

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130398 0
Dr Janet Schloss
Address 130398 0
National Centre for Naturopathic Medicine, Southern Cross University 1 Military Road, Lismore, NSW 2480
Country 130398 0
Australia
Phone 130398 0
+61 436101306
Fax 130398 0
Email 130398 0
[email protected]
Contact person for public queries
Name 130399 0
Janet Schloss
Address 130399 0
National Centre for Naturopathic Medicine, Southern Cross University, 1 Military Road, Lismore NSW 2480
Country 130399 0
Australia
Phone 130399 0
+61 436101306
Fax 130399 0
Email 130399 0
[email protected]
Contact person for scientific queries
Name 130400 0
Janet Schloss
Address 130400 0
National Centre for Naturopathic Medicine, Southern Cross University, 1 Military Road, Lismore NSW 2480
Country 130400 0
Australia
Phone 130400 0
+61 436101306
Fax 130400 0
Email 130400 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
As this is an industry funding trial, but independently conducted, the university would need to have approval from the funder to share information.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.