The efficacy of Larri® Oral Spray in the management of Laryngopharyngeal reflux disease.
The efficacy of Larri® Oral Spray in the management of pepsin salivary test positive Laryngopharyngeal reflux disease.
ENT Technologies Pty Ltd
80 participants
Apr 1, 2022
Interventional
Conditions
Summary
Hypothesis: Larri Oral spray will have symptomatic benefit as measured by the RSI questionnaire. Method: 80 patients will be recruited from our ENT clinics at a tertiary centre in Monash Health. Patients will need to be clinically diagnosed to have laryngopharyngeal reflux by their laryngologist and then test positive on a salivary pepsin test to be included. They will then be recruited and randomised into either receiving Larri Oral Spray or a Placebo spray for eight weeks. Prior to commencing their therapy, a baseline Symptom questionnaire will be taken, and then after eight weeks this will then be repeated. Patients already on anti-reflux medication will be allowed to continue their medication
Eligibility
Inclusion Criteria1
- Patients who have been clinically diagnosed as having laryngopharyngeal reflux by a laryngologist and test positive for a pepsin salivary test.
Exclusion Criteria1
- Oral cancer patients, oropharyngeal cancer patients, pregnant patients. and patients with a negative pepsin salivary test.
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Interventions
Arm 1 - Drug intervention arm Larri Oral Spray - Magnesium Alginate,Sodium Hyaluronate, and Camellia Sinensis LARRI PDE CODES: API: 68054 SIGMA: 10028542 SYMBION: 939315 CH2: 2549021 Dose: 2 sprays, four times a day Duration: eight weeks Mode: oral spray We will call patients after four and eight weeks to monitor adherence to the intervention through verbal confirmation.
Locations(1)
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ACTRN12622000366752