An Open-labelled, Prospective Clinical Trial to Evaluate the Safety & Efficacy of Alsarex in the Treatment of Acid Peptic Disorders

Objectives: To evaluate the clinical efficacy and safety of Alsarex Tablets in Acid Peptic Disorders. Material and Methods: A prospective, open-label clinical study was conducted on 300 patients of both sexes, aged between 18-65 years, confirmed with Acid Peptic Disorders from clinical examination, laboratory tests and who were willing to give informed consent. All patients received Alsarex Tablets at a dose of 1 tablet twice daily half hour before meals for 4 weeks. All patients were evaluated at baseline and 4 weeks using the Gastrointestinal Symptom Rating Scale (GSRS), a validated and standardized tool for assessing symptoms of acid peptic disorders. Observation: After 4 weeks of treatment, Alsarex Tablets showed significant reduction across all evaluated symptoms in the Gastrointestinal Symptom Rating Scale (GSRS); with p-values less than 0.001, indicating statistically significant reductions in symptom severity after treatment. The greatest improvements were noted in symptoms such as nausea, rumbling in the stomach, and loose stools, where the mean severity scores decreased notably from baseline values. Alsarex showed a broad therapeutic effect across diverse gastrointestinal symptoms, including pain or discomfort in the upper abdomen, heartburn, acid reflux, bloating, burping, and bowel movement irregularities. Result: Alsarex Tablets were found to be effective and safe in controlling the signs and symptoms of acid peptic disorders and its associated complications. There were no clinically significant adverse events either reported or observed during the entire study period. The overall compliance with the treatment was good and no treatment discontinuations were reported.