AN OPEN-LABELED, MULTICENTRIC, POST-MARKETING SURVEILLANCE (PMS) TO SUBSTANTIATE THE SAFETY AND EFFICACY OF SINAREST LEVO SYRUP IN PATIENTS OF COMMON COLD AND ALLERGIC RHINITIS

Dr. Mayuresh Kiran, Dr. Pramila Yadav, Mr. Lalit Pawaskar, Ms. Shruthi George

ABSTRACT

Introduction: The common cold is the most frequently encountered disease in medical practice. Patients continue to use medications that produce symptomatic relief because of the epidemiological relevance and the intensity of symptoms of flu-like syndromes and the common cold. This is a Phase IV study evaluated the efficacy and safety of Sinarest Levo Syrup in treatment of common cold and allergic rhinitis. Methodology: Of 172 enrolled, 152 patients completed the study. Efficacy assessment was made by reduction in TSS and four point Likert-type scales. Safety assessment was made by analyzing the adverse events during trial. Results: there was reduction in TSS from 7.65 (baseline) to 3.61 (day 3) and 1.28 (day 5). One point reduction in Likert-type symptom scale from Moderate to Mild took just 3 days. Nearly all the patients had >50% reduction in symptom score at all visit and majority of patients had complete relief from the symptom. 27 episodes of adverse events occurred and were of mild intensity. Conclusion: Sinarest Levo Syrup is safe and effective in the treatment of common cold and allergic rhinitis.

Keywords: Phenylephrine, Levocetirizine, Common Cold, Allergic Rhinitis, Total Symptom Score (TSS), Likert-type symptom severity scale.