A Prospective, Multi-centre, Open label, Single arm Study to Evaluate the Efficacy and Safety of Amlapitta Mishran Suspension in Participants with Amlapitta (Symptomatic Gastritis)

Introduction: The multi-center clinical study was conducted to revalidate the efficacy and safety of Amlapitta Mishran Suspension in Amlapitta (symptomatic gastritis) in a larger sample size in improving Amlapitta Symptom Rating Scale Score, PPDS score, EPS score, and safety. Methods: The study was a multi-centric, open-labeled, single-arm, prospective clinical trial in participants with Amlapitta (symptomatic gastritis). Participants with the presence of Amlapitta (symptomatic gastritis), as diagnosed by the Amlapitta Symptom Rating Scale Score ≥ 5 were included in the study. Participants were advised to take Amlapitta Mishran Suspension in a dose of 15 ml twice daily for 14 days. The study involved three visits. The investigator recorded the Amlapitta Symptom Rating Scale (ASRS) Score, Post Prandial Distress Syndrome (PPDS) Score, and Epigastric Pain Syndrome (EPS) Score at screening visit (Visit 1), baseline visit (Visit 2) and final visit (Visit 3). The p<0.05 was considered statistically significant measured by paired t-test or Wilcoxon Signed Rank test. Results: In the multi-center study 204 participants completed the study. At final visit, a statistically significant (p<0.001) reduction was reported in mean Total ASRS score, PPDS score, and EPS score as compared to the baseline scores. The individual ASRS, PPDS, and EPS variables also exhibited significant reduction (p<0.001) at the final visit. None of the participants reported any adverse events during the study. Conclusion: Amlapitta Mishran Suspension treatment for 14 days effectively and safely reduced the clinical symptoms of Amlapitta (symptomatic gastritis) assessed by Amlapitta Symptom Rating Scale, Postprandial Distress Syndrome and Epigastric Pain Syndrome scores.