The Role of Multi-Herbal Menthol Lozenges in the Treatment of Acute Sore Throat, Cough and Associated Symptoms

Background: Acute sore throat and cough are common complaints in primary care settings. Pharyngeal inflammation often leads to interconnected symptoms including throat pain, hoarseness and cough, which reduce quality of life. Topical therapies offer localised symptomatic relief through direct mucosal application. This study evaluated the efficacy of a multi-herbal menthol lozenge for treating acute sore throat, cough and associated symptoms. Methods: This prospective, open-label, single-arm study was conducted in Maharashtra, India (August-October 2010). Two hundred patients aged ≥ 6 years with recent onset sore throat were enrolled in two independent cohorts (N = 100 each) at separate investigation sites. Cohort A included patients with normal and severe disease course, while Cohort B only enrolled patients with normal disease. Patients received one 2.7 g lozenge every 2 hours or as needed (maximum 8 - 10 lozenges daily) for 3 days or up to 3 weeks in severe cases. Primary outcomes included changes from baseline in throat pain, inflammation, exudates, cough, and hoarseness assessed using visual analogue scales (VAS) and four-point rating scales. Secondary outcomes included adverse events and global impression scores. Results: All 200 patients completed the study (89% normal disease course in Cohort A, 100% in Cohort B). A statistically significant improvement in throat pain was observed from minute 15 onwards in both cohorts, with mean VAS scores decreasing from 2.85 to 0.03 (Cohort A) and 1.52 to 0.00 (Cohort B) by Day 3. Similar patterns were observed for inflammation (98.8% - 99.2% reduction), cough (91.8% - 97.1% reduction), and hoarseness (90.0% - 100% reduction). Complete symptom resolution was achieved in 92.1% - 97.1% of Cohort A patients and 84% - 100% of Cohort B patients by Day 3. Patients with severe disease (11% of Cohort A) showed progressive improvement, achieving complete recovery by Day 21. Global impression scores rated efficacy and safety as “excellent” or “good” in approximately 98% of cases. Only two patients experienced mild adverse events deemed unrelated to treatment. Conclusion: The multi-herbal menthol lozenge used in this study demonstrated rapid onset of action with significant symptomatic relief and an excellent safety profile, supporting its use for self-management of acute sore throat, cough and associated symptoms.