A PROSPECTIVE OBSERVATIONAL STUDY ON THERAPEUTIC EFFICACY AND SAFETY OF SIMETHICONE IN COMBINATION WITH ACTIVATED CHARCOAL IN PATIENTS WITH

Abstract

Dyspepsia is a common gastrointestinal disorder characterized by upper abdominal discomfort, bloating, postprandial fullness, belching, nausea, and early satiety, leading to a considerable reduction in quality of life. The present prospective observational study was conducted to evaluate the therapeutic efficacy and safety of simethicone in combination with activated charcoal in patients with dyspepsia. The study was carried out over six months at a tertiary care hospital in Hyderabad, India, and included 60 adult patients diagnosed with dyspepsia who received simethicone (80 mg) and activated charcoal (250 mg) as part of routine clinical management. Demographic characteristics, clinical symptoms, comorbidities, treatment patterns, therapeutic outcomes, and adverse drug reactions were assessed. The majority of patients were males (60%), with the highest prevalence observed in the 31–40-year age group. Combination therapy was prescribed to 60% of patients and demonstrated greater improvement in dyspeptic symptoms, including bloating, abdominal discomfort, flatulence, and postprandial fullness, compared with monotherapy. Safety evaluation revealed that 78.33% of patients experienced no adverse effects, while only a small proportion reported mild gastrointestinal complaints such as bloating, abdominal distension, or upper abdominal burning, indicating excellent tolerability. Overall, the findings suggest that the combination of simethicone and activated charcoal is an effective, safe, and well-tolerated therapeutic option for the symptomatic management of dyspepsia and provides valuable real-world evidence supporting its routine clinical use.