Clinical Trial of a Mouth and Throat Rinse for the Treatment of Acute Sore Throat

A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of an Antiviral Mouth and Throat Rinse for the Treatment of Acute Sore Throat (Upper Respiratory Tract Infection e.g., Pharyngitis/Laryngitis)

The aim of this study is to confirm the efficacy, safety and tolerability of the Mouth and Throat Rinse in adult participants with acute sore throat (upper respiratory tract infection e.g., pharyngitis/laryngitis) compared to placebo.

Inclusion Criteria:

• Subjects having clinical signs and symptoms of recent (less than 48 h) acute sore throat (upper respiratory tract infection) without signs of lower respiratory tract infection (total severity score for throat irritation baseline value ≥ 4).
• Centor Score of 0 to 3 points at screening.
• Female and male subjects with 18-75 years of age.

Exclusion Criteria:

• Known allergy to any of the components in the investigational product (Placebo or Verum) (i.e. SLS).
• Centor Score of 4 points at screening.
• Presence of exanthema.
• Presence of oral mucosal plaques e.g., soor.
• Presence of bacterial infection of the upper respiratory tract (confirmed by rapid screening test).