A Randomized, Open-Label, Phase IV Clinical Study to Compare the Safety and Efficacy of the Fixed-Dose Combination of Trypsin, Bromelain, and Rutoside versus Serratiopeptidase in Minor Surgical Wound

Abstract

To compare the safety, tolerability, and efficacy of the enteric-coated tablet containing fixed-dose combination (FDC) of trypsin 48 mg, bromelain 90 mg, and rutoside trihydrate 100 mg versus serratiopeptidase 10 mg for healing wounds after minor surgery. Methods: A prospective, multicenter, open-label, randomized, two-arm, active-controlled, phase IV study was performed. Eligible patients were randomized in a 1:1 ratio to receive either FDC or serratiopeptidase. Patients were evaluated on day 5±2 and day 10±2 along with a telephonic follow-up after seven days of the last dose. Medical examination, vital signs evaluation, and adverse events (AEs) and wound regeneration assessment were performed during follow-up. The global impression of tolerability and efficacy by patients and investigators were analyzed. SAS® version 9.4 was used for statistical analysis. Results: 383 eligible patients were randomized to the treatment groups. The treatments did not affect the laboratory parameters and vital signs significantly. Nine patients experienced AEs. No significant difference was observed by investigator and patients between both the treatments. FDC was significantly (p<0.05) high in wound regeneration on day 5±2. However, no significant difference was noted on day 10±2. A significant (p<0.05) improvement of total BWAT score in patients who received FDC was observed. The global impression efficacy evaluation by investigators and patients rated that FDC is comparatively efficacious in wound healing. Conclusion: The FDC of trypsin, bromelain, and rutoside trihydrate is equally safe and more efficacious as compared to serratiopeptidase in wound healing.