Official Title
A Randomized Placebo-controlled Crossover Trial Assessing the Efficacy and Safety of M-Gard Particulate EW in the Treatment of Seasonal Allergic Rhinitis
Brief Summary

The goal of this clinical trial is to assess the efficacy and safety of M-Gardsupplementation for alleviating the symptoms of allergic rhinitis.

Detailed Description

Not Provided

Not yet recruiting
Allergic Rhinitis Due to Grass Pollens

Dietary Supplement: M-Gard

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

Other: Placebo

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

Eligibility Criteria

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

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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 65 Years
Countries
Australia
Locations

RDC Clinical
Brisbane, Queensland, Australia

Investigator: Amanda Rao
Contact: +61 (07) 3102 4486
amanda@rdcglobal.com.au

Contacts

Amanda Rao
+61 (0) 7 3102 4486
research@rdcglobal.com.au

Thomas Tompkins, Study Director
Lallemand Bio-Ingredients

Lallemand Bio-Ingredients
NCT Number
Keywords
allergic rhinitis
MeSH Terms
Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal