Status:
RECRUITING
M-Gard Particulate EW Efficacy Study on Seasonal Allergic Rhinitis
Lead Sponsor:
RDC Clinical Pty Ltd
Collaborating Sponsors:
Lallemand Bio-Ingredients
Conditions:
Allergic Rhinitis Due to Grass Pollens
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The goal of this clinical trial is to assess the efficacy and safety of M-Gard supplementation for alleviating the symptoms of allergic rhinitis.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
June 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06907680
Start Date
June 27 2025
End Date
January 1 2026
Last Update
November 18 2025
Active Locations (1)
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1
RDC Clinical
Brisbane, Queensland, Australia, 4006