M-Gard Particulate EW Efficacy Study on Seasonal Allergic Rhinitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-27

Study Completion Date

2026-01-31

Brief Summary

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

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Detailed Description

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Conditions

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Allergic Rhinitis Due to Grass Pollens

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized, double-blind, placebo-controlled, cross-over trial

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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M-Gard

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

Group Type EXPERIMENTAL

M-Gard

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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M-Gard

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type OTHER

Other Intervention Names

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M-Gard Particulate EW

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes