None listed
Conditions
Brief 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
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.
Sponsors
ENT Technologies Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients who have been clinically diagnosed as having laryngopharyngeal reflux by a laryngologist and test positive for a pepsin salivary test.
Exclusion criteria
Oral cancer patients, oropharyngeal cancer patients, pregnant patients. and patients with a negative pepsin salivary test.
Outcome results
None listed