Efficacy and Safety of the Lysobact Complete Spray®, Tantum Verde® and Pharyngal® Oromucosal Spray in the Treatment of Acute Sore Throat
Sore Throat
About this trial
This is an interventional treatment trial for Sore Throat focused on measuring acute sore throat, lysobact
Eligibility Criteria
Inclusion Criteria:
- Patients with acute tonsillo-pharyngitis symptoms in common cold and by using a scale-based symptom Tonsillo-Pharyngitis Assessment (TPA) as an objective finding of pharyngeal infection, with a score of ≥5
- Patients who will be treated only on a symptomatic treatment basis, and with a prescribed a oropharyngeal spray
- Patients, 18 years of age and above, who provided an informed consent
- Patients with a sore-throat of recent onset, symptoms initiated ≤48 hours
- Patients with sore throat pain rated ≥66 mm on the Sore Throat Pain Intensity Scale (STPIS)
- Patients with difficulty in swallowing rated ≥50 mm on Difficulty Swallowing Scale (DSS)
- Patients with a sensation of swollen throat rated ≥33 mm on the Swollen Throat Scale (SwoTS)
Exclusion Criteria:
- Patients who had any previous (within 4 hours prior to screening examination) throat lozenge treatment/use
- Patients who had used any flu-preparation which contains any analgesic ingredient such as paracetamol, ibuprofen or acetylsalicylic acid (ASA) along with a decongestant
- Patients who had analgesic use (any) 4 hours prior to the screening examination
- Patients who are prescribed an antibiotic use before the screening visit and are entitled to use antibiotics during the course of this non-interventional study
- Patients with a known hypersensitivity to active/inactive ingredients of medications which is prescribed for the symptomatic treatment of sore throat
- Patients with known hypersensitiveness to egg white and other allergens
- Patients who are pregnant or breastfeeding
Sites / Locations
- University Clinical Center of the Republic of Srpska, ENT Clinic, Banja Luka, Bosnia and Herzegovina
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Active Comparator
Active Comparator
Placebo Comparator
Lysobact Complete Sprey
Tantum Verde® Spray
Pharyngal® Oromucosal Spray
Placebo
Lysobact Complete Sprey Route of administration: Oromucosal spray, sprayed directly toward the affected area with the applicator while the mouth is wide open Dose regimen: Sprayed 3 to 6 doses a day. For a single dose, spraying pump should be pressed 5 times and one press of the spray pump release 0.20 mL of the solution containing 4 mg lysozyme, 0.3 mg cetylpyridine and 0.1 mg lidocaine hydrochloride.
Tantum Verde® Spray Route of administration: Oromucosal spray, sprayed directly toward the affected area with the applicator while the mouth is wide open. Dose regimen: Sprayed 4 to 8 doses, 2 to 6 times a day. One press means one dose.
Pharyngal® Oromucosal Spray Route of administration: Oromucosal spray, sprayed directly toward the affected area with the applicator while the mouth is wide open. Dose regimen: Sprayed 2 to 4 doses, repeated 6 to 10 times per day. One press of the pump (one dose) releases 0.14 ml of the solution with 0.28 mg chlorhexidine digluconate and 0.07 mg of lidocaine hydrochloride.
Route of administration: Sprayed directly toward the affected area with the applicator while the mouth is wide open. Dose regimen: Sprayed 3 to 6 doses a day. For a single dose, spraying pump should be pressed 5 times.