Study to Evaluate the Efficacy and Safety of Different Doses of Grammidin With Anesthetic Spray Compared With Septolete Total Lozenges in Treating Acute Infectious and Inflammatory Pharyngeal Diseases

What this Trial Is About

This research aims to evaluate the effectiveness and safety of different doses of the drug Grammidin with anesthetic, delivered as a metered dose topical spray, for treating acute infectious and inflammatory diseases of the pharynx. These conditions include acute pharyngitis, nasopharyngitis, and exacerbation of chronic pharyngitis. The study compares Grammidin spray with Septolete Total lozenges as an active comparator in a Phase 2 randomized trial. Participants are assigned to one of three groups: one group receives Grammidin spray with 2 sprays every 6 hours three times daily for 7 days, another group receives Grammidin spray with 4 sprays on the same schedule, and the third group takes Septolete Total lozenges (1 lozenge every 6 hours, up to 3 lozenges daily) for 7 days. Treatments are taken under fed conditions. The study is open-label, multicenter, and parallel-group. During the 8-day study period, participants attend visits on Day 1, Day 5, and Day 8 for assessments including sore throat severity measured by Visual Analog Scale (VAS) and the Clinical Symptom Severity Scale. Researchers monitor clinical symptoms, inflammation signs, and intoxication syndrome. Safety is evaluated through recording adverse events, vital signs, physical examinations, and multiple laboratory tests such as blood counts, blood chemistry, and urinalysis. The study tracks treatment adherence and overall patient outcomes over the three visits.

Study to Evaluate the Efficacy and Safety of Different Doses of Graminidin With Anesthetic, a Metered Dose Topical Spray, in the Treatment of Acute Infectious and Inflammatory Pharyngeal Diseases Compared With Drug Septolete Total, Lozenges