Safety and efficacy of trypsin, bromelain, rutoside, and diclofenac compared to diclofenac in wound healing: a randomized parallel study

Objective: To evaluate and compare the safety and efficacy of enteric tablet containing fixed-dose combination (FDC) of trypsin 48 mg, bromelain 90 mg, rutoside trihydrate 100 mg, and diclofenac sodium 50 mg versus similar formulation containing diclofenac sodium 50 mg for healing wounds.
Methods: In a multicenter, open label, randomized, comparative clinical study, patients with surgical wounds were randomized to receive either FDC–ENZOMAC PLUS or diclofenac 50 mg gastro-resistant tablets. Safety was evaluated by assessing incidence of adverse events, while efficacy was evaluated using Bates-Jensen wound assessment tool.
Results: A total of 18 AEs were observed throughout the study period. There was no significant difference in AEs occurrence between both the treatment groups. Majority of AEs were mild in nature with two AEs of moderate intensity. On day 10±2, FDC showed wound regeneration in 94.15% patients while diclofenac showed wound regeneration in 88.30% patients.