The goal of this clinical trial is to assess the efficacy and safety of M-Gard supplementation for alleviating the symptoms of allergic rhinitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
20
RDC Clinical
Brisbane, Queensland, Australia
RECRUITINGRelief of symptoms of allergic rhinitis
Relief of symptoms of allergic rhinitis, as measured by: Total and individual allergic rhinitis symptom severity as measured by a visual analogue scale (VAS) of nasal congestion, sneezing, itchy nose, runny nose and watery eyes. These symptoms will be rated on a scale of 0 to 10 where 0 is "not troublesome at all" and 10 is "very troublesome".
Time frame: Day 0 to Day 43
Reflective Total Nasal Symptom Scores (rTNSS)
Change from baseline to the end of the study period in Reflective Total Nasal Symptom Scores (rTNSS). Self-reported questionnaire rating the severity of four nasal symptoms (runny nose, nasal congestion, itchy nose, and sneezing) on a four-point scale (0-3), where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. The rTNSS is the sum of the scores for each of the nasal symptoms (from 0 to 12)
Time frame: Day 0 to Day 43
Reflective Total Ocular Symptom Scores (rTOSS)
Change from baseline to the end of the study period in Reflective Total Ocular Symptom Scores (rTOSS). Self-reported questionnaire that is calculated as the sum of the patients' scoring of the severity of three ocular symptoms (itching/burning, tearing/watering, and redness) on a scale of 0-3 where 0 = absent, 1 = mild, 2 = moderate, and 3 = severe).
Time frame: Day 0 to Day 43
Rhinitis Control Scoring System (RCSS)
Change from baseline to the end of the study period in Rhinitis Control Scoring System (RCSS). Subject-completed tool including 5 items (sneezing, rhinorrhoea, nasal obstruction, nasal pruritus, and conjunctivitis). Each symptom is rated on a 5-point scale depending on its intensity (none-10%, mild-8%, moderate-6%, severe-4%, very severe-2%) and its frequency (never-10%, rarely-8%, occasionally-6%, frequently-4%, very frequently-2%), which are assessed separately. The sum of the intensity score and the frequency score gives the global score
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Time frame: Day 0 to Day 43
Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ).
Change from baseline to the end of the study period in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). Self-reported questionnaire used measure the functional impairments that are most troublesome to patients because of their rhinoconjunctivitis. It consists of 28 questions in 7 domains (activity limitation, sleep problems, nose symptoms, eye symptoms, non-nose/eye symptoms, practical problems and emotional function). These are rated on a 7-point scale (0 = not impaired at all - 6 = severely impaired).
Time frame: Day 0 to Day 43
Peak Nasal Inspiratory Flow (PNIF)
Change from baseline to the end of the study period in Peak Nasal Inspiratory Flow (PNIF). Peak nasal inspiratory flow (PNIF) is a measure of nasal patency and measures the maximum airflow a patient is able to produce during forced nasal inspiration. PNIF (in L/min) will be measured with a peak inspiratory flow meter. The highest of three successive measurement values will be recorded
Time frame: Day 0 to Day 43
Onset of action of treatment
Change from baseline to the end of the study period in onset of action of treatment, this will be measured during the nasal allergen challenge. Peak nasal inspiratory flow (PNIF) will be measured to assess for nasal patency and allergy symptoms will be rated via the VAS, rTNSS, rTOSS, RCSS and RQLQ. The time from the onset of symptoms to their resolution will be measured.
Time frame: Day 12 and Day 41
Pathology markers
Change from baseline to the end of the study period in Pathology markers: cytokines, histamine, tryptase, allergen specific IgE.
Time frame: Day 0 to Day 41
Use of rescue /concomitant medications
Change from baseline to the end of the study period in use of rescue /concomitant medications.
Time frame: Day 0 to Day 43
Safety - Adverse events
Change from baseline to the end of the study period in Safety via Adverse Event reporting and incident rate ratio between placebo and treatment groups.
Time frame: Day 0 to Day 43
Safety - Vital Signs (Blood Pressure)
Change from baseline to the end of the study period in Safety via Vital Signs (blood pressure).
Time frame: Day 0 to Day 41
Safety - Vital Signs (Heart Rate)
Change from baseline to the end of the study period in Safety via Vital Signs heart rate.
Time frame: Day 0 to Day 41
Safety - Vital Signs (O2 saturation)
Change from baseline to the end of the study period in Safety via Vital Signs (O2 saturation).
Time frame: Day 0 to Day 41
Safety - Vital Signs (temperature)
Change from baseline to the end of the study period in Safety via Vital Signs (temperature).
Time frame: Day 0 to Day 41
Safety - Safety Markers (FBC)
Change from baseline to the end of the study period in Safety via Safety Markers (Full Blood Count).
Time frame: Day 0 to Day 41
Safety - Safety Markers (E/LFT)
Change from baseline to the end of the study period in Safety via Safety Markers (E/LFT).
Time frame: Day 0 to Day 41