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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06907680




Registration number
NCT06907680
Ethics application status
Date submitted
27/03/2025
Date registered
2/04/2025

Titles & IDs
Public title
M-Gard Particulate EW Efficacy Study on Seasonal Allergic Rhinitis
Scientific title
A Randomized Placebo-controlled Crossover Trial Assessing the Efficacy and Safety of M-Gard Particulate EW in the Treatment of Seasonal Allergic Rhinitis
Secondary ID [1] 0 0
BETALL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Allergic Rhinitis Due to Grass Pollens 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Allergies
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - M-Gard
Other interventions - Placebo

Experimental: M-Gard - One capsule containing 250mg of M-Gard Particulate EW is taken twice daily for 14 days.

Placebo comparator: Placebo - One capsule containing 250mg of MCC (Microcrystalline Cellulose) is taken twice daily for 14 days.


Treatment: Other: M-Gard
One capsule containing 250mg of M-Gard Particulate EW is taken twice daily for 14 days.

Other interventions: Placebo
One capsule containing 250mg of MCC (Microcrystalline Cellulose) is taken twice daily for 14 days.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Relief of symptoms of allergic rhinitis
Timepoint [1] 0 0
Day 0 to Day 43
Secondary outcome [1] 0 0
Reflective Total Nasal Symptom Scores (rTNSS)
Timepoint [1] 0 0
Day 0 to Day 43
Secondary outcome [2] 0 0
Reflective Total Ocular Symptom Scores (rTOSS)
Timepoint [2] 0 0
Day 0 to Day 43
Secondary outcome [3] 0 0
Rhinitis Control Scoring System (RCSS)
Timepoint [3] 0 0
Day 0 to Day 43
Secondary outcome [4] 0 0
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ).
Timepoint [4] 0 0
Day 0 to Day 43
Secondary outcome [5] 0 0
Peak Nasal Inspiratory Flow (PNIF)
Timepoint [5] 0 0
Day 0 to Day 43
Secondary outcome [6] 0 0
Onset of action of treatment
Timepoint [6] 0 0
Day 12 and Day 41
Secondary outcome [7] 0 0
Pathology markers
Timepoint [7] 0 0
Day 0 to Day 41
Secondary outcome [8] 0 0
Use of rescue /concomitant medications
Timepoint [8] 0 0
Day 0 to Day 43
Secondary outcome [9] 0 0
Safety - Adverse events
Timepoint [9] 0 0
Day 0 to Day 43
Secondary outcome [10] 0 0
Safety - Vital Signs (Blood Pressure)
Timepoint [10] 0 0
Day 0 to Day 41
Secondary outcome [11] 0 0
Safety - Vital Signs (Heart Rate)
Timepoint [11] 0 0
Day 0 to Day 41
Secondary outcome [12] 0 0
Safety - Vital Signs (O2 saturation)
Timepoint [12] 0 0
Day 0 to Day 41
Secondary outcome [13] 0 0
Safety - Vital Signs (temperature)
Timepoint [13] 0 0
Day 0 to Day 41
Secondary outcome [14] 0 0
Safety - Safety Markers (FBC)
Timepoint [14] 0 0
Day 0 to Day 41
Secondary outcome [15] 0 0
Safety - Safety Markers (E/LFT)
Timepoint [15] 0 0
Day 0 to Day 41

Eligibility
Key inclusion criteria
* Adults aged 18-65 years.
* Generally healthy
* Individuals with a history of recurrent seasonal allergic rhinitis
* Positive RAST test for grass allergy
* BMI 18-35kg/m2
* Able to provide informed consent
* Agree not to change current diet and/or exercise routine during entire enrolment period
* Agree to not participate in another clinical trial during the study period
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Serious illness e.g., liver disease, kidney disease, heart disease, mood disorders, neurological disorders such as multiple sclerosis.
* Unstable illness e.g., diabetes and thyroid gland dysfunction.
* Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years.
* Individuals with symptomatic perennial allergic rhinitis, non-allergic rhinitis, chronic respiratory conditions (e.g., asthma, chronic obstructive pulmonary disease).
* Participants with cognitive damage.
* Acute illness experienced in the past 1 month.
* Active smokers and/or nicotine or drug abuse.
* Allergic to any of the ingredients in the active or placebo formula.
* Chronic past and/or current alcohol use (>21 alcoholic drinks per week)
* Attempting to conceive, pregnant or lactating women
* Use of medications that would affect the immune and/or the inflammatory response e.g. immunotherapy, antihistamines (daily use), corticosteroids, mast cell stabilizers, leukotriene modifiers, and decongestants.
* Currently taking Coumadin (Warfarin), Heparin, Dalteparin, Enoxaparin or other anticoagulation therapy including low dose aspirin; tricyclic antidepressants; Clonidine and other central acting alpha-2-agonists.
* Participants who are currently participating in any other clinical trial or who have participated in any other clinical trial during the past 1 month.
* Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/05/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
RDC Clinical - Brisbane
Recruitment postcode(s) [1] 0 0
4006 - Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
RDC Clinical Pty Ltd
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Lallemand Bio-Ingredients
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Thomas Tompkins
Address 0 0
Lallemand Bio-Ingredients
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amanda Rao
Address 0 0
Country 0 0
Phone 0 0
+61 (0) 7 3102 4486
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06907680