This paper is published in Volume-7, Issue-1, 2021
Area
Medicine And Pharmacy
Author
Ashish Mungantiwar, Nirali Bhatt, Priyanka Shrivastava, Jitendra More
Org/Univ
Macleods Pharmaceuticals Ltd, Mumbai, Maharashtra, India
Pub. Date
15 January, 2021
Paper ID
V7I1-1154
Publisher
Keywords
Bromelain, Chymotrypsin, Healing, Ruto Side, Trypsin, Wound

Citationsacebook

IEEE
Ashish Mungantiwar, Nirali Bhatt, Priyanka Shrivastava, Jitendra More. A multicenter, open-label, randomized, phase IV clinical study comparing the safety and effectiveness of the fixed-dose combination of trypsin, bromelain, and rutoside with standard therapy in the management of wound due to minor surgery, International Journal of Advance Research, Ideas and Innovations in Technology, www.IJARIIT.com.

APA
Ashish Mungantiwar, Nirali Bhatt, Priyanka Shrivastava, Jitendra More (2021). A multicenter, open-label, randomized, phase IV clinical study comparing the safety and effectiveness of the fixed-dose combination of trypsin, bromelain, and rutoside with standard therapy in the management of wound due to minor surgery. International Journal of Advance Research, Ideas and Innovations in Technology, 7(1) www.IJARIIT.com.

MLA
Ashish Mungantiwar, Nirali Bhatt, Priyanka Shrivastava, Jitendra More. "A multicenter, open-label, randomized, phase IV clinical study comparing the safety and effectiveness of the fixed-dose combination of trypsin, bromelain, and rutoside with standard therapy in the management of wound due to minor surgery." International Journal of Advance Research, Ideas and Innovations in Technology 7.1 (2021). www.IJARIIT.com.

Abstract

Wound healing is a complex process consisting of steps–hemostasis, inflammation, proliferation, and remodeling. The purpose of this multicenter, open-label, randomized, active-controlled, prospective, two-arm, phase IV clinical study was to evaluate and compare the safety, tolerability, and efficacy of fixed-dose combination (FDC) enteric-coated tablets of trypsin 96 mg + bromelain 180 mg + rutoside trihydrate 200 mg–Enzomac Forte with the enteric-coated tablets of trypsin-chymotrypsin 100000 AU–marketed formulation in the complex wound healing process. An open-label, randomized, parallel, active-controlled, two-arm, phase IV clinical study was conducted at 13 centers in India from December 02, 2017, to May 04, 2019. Adult patients aged 18-65 years (both inclusive) fulfilling the eligibility criteria were included. These patients were randomized into two treatment groups–FDC versus trypsin-chymotrypsin. Adverse events (AEs) and serious adverse events (SAEs) were recorded to evaluate and compare the safety and tolerability. The efficacy of both the treatment in the management of wound healing was noted and compared. AEs were reported in five patients; no SAEs were reported. No clinically significant differences in the occurrence of AEs were found; thus, both the treatments were safe and tolerable. The wound regeneration efficacy on day 10±2 was significantly higher with FDC as compared to trypsin-chymotrypsin. A significantly high improvement of total BWAT score with FDC as compared to trypsin-chymotrypsin was observed. FDC used by the authors in this study was found to be equally safe and tolerable and more effective than the marketed formulation used for wound healing after a minor surgical procedure.
Paper PDF