Evaluation of Efficacy and Safety of ‘AHPL/AYTOP/2014A’ in Patients Suffering from Aphthous Ulcers - An Open Label, Randomized, Multi-center, Prospective, Active Controlled, Parallel Group, Clinical Study

Background: Aphthous stomatitis is a painful and often inflammatory condition. Objective of the study is to evaluate safety and efficacy of Arimu mouth ulcer gel (AHPL/ AYTOP/2014A) in subjects suffering from aphthous ulcers. Methods: This study compared effect of Arimu mouth ulcer gel (Group I), with sponsors other mouth ulcer gels (Group II, Group III), marketed Ayurvedic formulation (Group IV), and conventional preparation (Group V). Subjects were advised to apply given formulations twice daily for 14 days or till complete healing of ulcer whichever was earlier. Results: A total of 276 subjects completed the study. Statistically significant reduction in the mean pain score (VAS) was observed from first follow up visit and continued till the end of the study in all the groups. If compared, the reduction in the mean pain score was significantly more in Group I than Group II, Group III and Group IV and comparable to that of Group V on Day 3. On other follow up visits, change was comparable between the groups and the difference was not significant. The same trend had been observed for burning sensation. Onset of action was less and duration of action was longer in group I compared to other groups. The number of days required to heal ulcer was less in group I than other groups. Adverse events such as vomiting and fever occurred which were not related to study drugs and did not require discontinuation of the study treatment. Conclusion: Arimu mouth ulcer gel is safe and effective in treating aphthous ulcer.