The Impact of the Combination of Proteolytic Enzyme and Rutin on the Post-operative Management of Inflammation: A Randomized, Controlled, Double-Blind, Comparative Clinical Trial.

Autor:	Rathi PC; Research and Development, Advanced Vital Enzymes Private Limited (ADVENZA), Thane, IND., Rathi CL; Research and Development, Advanced Vital Enzymes Private Limited (ADVENZA), Thane, IND., Risbud SP; Research and Development, Advanced Vital Enzymes Private Limited (ADVENZA), Thane, IND., Ganu GP; Pharmacology, Mprex Healthcare Pvt. Ltd., Pune, IND.
Jazyk:	angličtina
Zdroj:	Cureus [Cureus] 2024 Oct 26; Vol. 16 (10), pp. e72420. Date of Electronic Publication: 2024 Oct 26 (Print Publication: 2024).
DOI:	10.7759/cureus.72420
Abstrakt:	Introduction Post-operative wound infections are a common complication that may impede recovery and require longer hospital stays. These infections substantially impact patient outcomes, increasing the likelihood of complications and healthcare expenses. Effective management of inflammation and pain is crucial for optimizing post-operative care. Method In this study, a total of 65 patients were randomized to either one of the three groups - EnMax tablet (Advanced Vital Enzymes Private Limited (ADVENZA), Thane, India) along with standard of care (SOC), Placebo tablet along with SOC, and Marketed reference preparation along with SOC. Follow-up visits were conducted on days 1, 3, 6, and 8. Results On day 8, EnMax demonstrated a statistically significant reduction in inflammation scores of 91.49%, compared to 80% with the marketed reference preparation and 63.64% with placebo. The EnMax group also showed a greater reduction in Visual Analog Scale (VAS) pain scores of 95.29% compared to the marketed reference preparation of 86.42%. Significant reductions in C-reactive protein (CRP) of 51.24% and erythrocyte sedimentation rate (ESR) at 59.80% were observed in the EnMax group, while the marketed reference preparation showed reductions of 35.23% and 46.38%, respectively. Both patient and investigator assessments favored EnMax over the marketed reference and placebo formulation. The study reported no adverse events, with stable vital signs and clinically insignificant changes in complete blood count (CBC), indicating the safety and tolerability of the investigational products. Conclusion EnMax, a combination of systemic microbial and plant proteases with the herbal component rutin, achieved significant reductions in post-operative inflammation, pain, and analgesic use, and improved overall patient and investigator assessment scores, outperforming placebo and demonstrating comparable, slightly superior efficacy to the marketed reference preparation. This study not only serves as a valuable guideline for current clinical practice in managing post-surgical inflammation and pain but also establishes a robust baseline for further research in postoperative care and other inflammatory conditions. Competing Interests: Human subjects: Consent for treatment and open access publication was obtained or waived by all participants in this study. 1. Institutional Ethics Committee, Sangvi Multispeciality Hospital; 2. Institutional Ethics Committee, Lokmanya Medical Research Centre issued approval 1. ECR/1865/Inst/MH/2023; 2. ECR/175/Inst/MH/2013/RR-19. The study was conducted after the Ethics Committee's approval. Ethics Committee approval was obtained from: 1. Institutional Ethics Committee, Sangvi Multispeciality Hospital: ECR/1865/Inst/MH/2023, 2. Institutional Ethics Committee, Lokmanya Medical Research Centre: ECR/175/Inst/MH/2013/RR-19. Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue. Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: Piyush C. Rathi declare(s) a grant from Advanced Vital Enzymes Private Limited (ADVENZA). Chandrakant L. Rathi declare(s) a grant from Advanced Vital Enzymes Private Limited (ADVENZA). Shilpa P. Risbud declare(s) employment from Advanced Vital Enzymes Private Limited (ADVENZA). Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work. (Copyright © 2024, Rathi et al.)
Databáze:	MEDLINE
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