Efficacy of high-dose serrapeptase (serratiopeptidase) in inflammation among orthopedic trauma patients.

Pain and inflammation resulting from orthopedic trauma have a significant negative impact on early recovery and rehabilitation. A proteolytic enzyme called serrapeptase (serratiopeptidase), which has anti-inflammatory properties, has been used with increasing frequency in surgery and trauma-related surgery. Nevertheless, clinical evidence of its efficacy in orthopedic trauma remains scant. The objective of the study was to determine the effectiveness, safety, and tolerability of high-dose serrapeptase (serratiopeptidase; DANZ-N 30 mg) used as an adjunctive therapy in reducing inflammation and pain in patients with orthopedic trauma. This was a prospective, multicenter, real-world observational study that enrolled 850 patients with orthopedic trauma injuries. Group assignment was at the discretion of the treating physician: patients received either conventional trauma care alone or conventional trauma care combined with oral serrapeptase. Pain intensity was assessed using a Visual Analog Scale (VAS), and inflammatory changes were systematically monitored over 15 days. Adverse events were systematically recorded to assess safety. In total, 408 patients in the serrapeptase group and 405 in the conventional-treatment group completed the study. VAS scores declined significantly faster in the serrapeptase group, with a mean difference of 1.4 points by day 15 (P < 0.001). All inflammatory signs resolved more rapidly with serrapeptase (P < 0.001 across all parameters by day 15). Adverse events were mild and comparable between groups, with no serious events reported. Adjunctive serrapeptase (serratiopeptidase; DANZ-N 30 mg) was associated with lower pain scores and fewer clinical signs of inflammation in orthopedic trauma patients.