efficacy of natural seawater based throat spray in acute sore throat relief

Conditions: Sore Throat

Summary: prospective, randomized, double-blind, placebo-controlled, multicentre clinical trial to assess the efficacy and tolerability of natural seawater based throat spray among adult patients with acute sore throat.


Eligibility criteria:
inclusion criteria: * 1. adults (male or female) aged ≥ 18 years old. * 2. patients with complaint of sore throat ≤ 72h. * 3. sore throat exclusively due to upper respiratory tract infection (tonsillitis, pharyngitis, rhinopharyngitis). * 4. clinical confirmation by the physician for the presence of typical signs (spontaneous pain, local inflammation) of acute pharyngitis or tonsillitis. * 5. pain intensity scored by patient on the 5-point descriptive pain intensity scale as slight, mild or moderate. * 6. willingness to provide written informed consent prior to perform of any study related procedure. * 7. subjects agreeing to follow the study requirements during the whole study period (including forbidden medication and food supplements). * 8. subjects agreeing not to modify their lifestyle habits during the whole study period (diet, physical activity). * 9. subject affiliated to social security. * 10. subject able to understand verbal and written local language and in capacity to fill-in patient diary by himself/herself. exclusion criteria: * 1. previous history of allergy or known intolerance to one of the following formulation ingredients: seawater, vegetable glycerin, mint, lemon, acacia honey, propolis, essential oils. * 2. active smokers. * 3. fever \> 38°c at randomization. * 4. past or current throat phlegmon. * 5. past or current seasonal allergy. * 6. past or current asthma. * 7. past or current chronic rhinosinusitis. * 8. past or current chronic obstructive pulmonary disease (copd). * 9. past or current ent (ear, nose and throat) cancer. * 10. acute rhinosinusitis. * 11. controlled or uncontrolled diabetes. * 12. gastroesophageal reflux disease (gerd). * 13. known immunodeficiency. * 14. any painful condition that may distract attention from sore throat pain (ex: mouth ulcers etc.) or that requires analgesic usage. * 15. any disease that may interfere with the study aim from investigator's opinion. * 16. evidence of mouth breathing or severe coughing. * 17. patient with severe pain intensity on 5-point descriptive pain intensity scale. * 18. subjects taking: * chronic treatment for throat or other ent pathology, * current antibiotherapy or stopped less than 2 weeks before inclusion, * chronic treatment (\>3 months) with local or systemic corticotherapy, or immunotherapy, * local or systemic antihistaminic. * 19. subjects refusing to stop at entry into the study: * throat spray, lozenge, pastille, * local throat or systemic analgesic, * medicated confectionary, * nasal wash and spray, * nasal corticosteroid or antihistaminic nasal spray, * medication to gargle, * honey, propolis, or any sore throat home remedies. * 20. known liver disease or hypersensitivity to paracetamol. * 21. pregnant, breastfeeding or seeking pregnancy women. * 22. positive result from rapid strep throat test. * 23. subjects already included once in this study. * 24. subjects participating in another clinical trial or in the exclusion period to another study. * 25. subjects having a member of his/her home who is currently participating to this study.