M-Gard Particulate EW Efficacy Study on Seasonal Allergic Rhinitis

RDC Clinical

Status and phase: Not yet enrolling; Phase 2

Conditions: Allergic Rhinitis Due to Grass Pollens

Treatments: Other: Placebo; Dietary Supplement: M-Gard

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06907680

BETALL

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

M-Gard

Experimental group

Description:

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

Treatment:

Dietary Supplement: M-Gard

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo