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A Randomized, Clinical Trial to Evaluate Efficacy and Tolerability of Trypsin:Chymotrypsin as Compared to Serratiopeptidase and Trypsin:Bromelain:Rutoside in Wound Management

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An Erratum to this article was published on 28 February 2017

Abstract

Introduction

Systemic enzyme therapy can play an important role in maintaining normal inflammatory processes within the body and thereby helps support and speed up healing. In the course of the anti-inflammatory action, enzymes degrade damaged cells and necrotic material and, through the inactivation of mediators and toxic products, they restrict the edema and pain.

Method

The study conducted at Grant Medical College, Mumbai, India was a clinical trial comparing the efficacy and tolerability of three oral enzyme treatment groups—oral tablets containing trypsin:chymotrypsin (TC) (Chymoral Forte®), serratiopeptidase (S) 5 mg oral tablets, and oral enzyme tablets containing trypsin 48 mg, bromelain 90 mg, and rutoside 100 mg (TBR)—to evaluate their healing potential in surgical wounds after orthopedic surgery.

Results

A total of 75 patients were screened, randomized, and divided into three groups in 1:1:1 ratio receiving either of the three treatments. In the TC group, erythema was significantly reduced from 3.44 on day 3 to 1.16 on day 10 (p < 0.01). There was significantly better reduction in erythema scores in the TC group as compared to S and TBR groups (p < 0.05) at each follow-up visit. Similarly reduction in the local irritation, wound discharge, edema, induration, and tenderness score with TC treatment at the end of the study was significantly higher than that observed in the other two groups. In addition TC showed significant reduction in pain on the VAS scale (p < 0.01). Global assessment of response to therapy for efficacy and tolerability was reported to be good to excellent in 88% and 92% of the patients on TC as compared to 12% and 8% with S and 12% and 8% with TBR.

Conclusion

TC provides a better resolution of symptoms of inflammation after orthopedic surgery as compared to S and TBR, thus facilitating better wound healing. Further studies are warranted to confirm the findings.

Trial Registration

Clinical Trial Registry of India (Reg. No. CTRI/2011/07/001920).

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Acknowledgements

Sponsorship for this study was funded by Elder Pharmaceuticals Ltd. and article processing charges were funded by Torrent Pharmaceuticals Limited. In June 2014, Torrent Pharmaceuticals Limited acquired part of the formulation business of Elder Pharmaceuticals Limited in India and Nepal which includes product Chymoral Forte®.

All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship of this manuscript, take responsibility for the integrity of the work as a whole, and have given final approval for the version to be published.

Editorial assistance in the preparation of this manuscript was provided by Dr. Deepak Langade of Clinsearch Healthcare Solutions Pvt. Ltd and support for this assistance was funded by Elder Pharmaceuticals Ltd.

Disclosures

Ajay Chandanwale, Deepak Langade, Piyush Gavai, and Dhiraj Sonawane have nothing to disclose.

Compliance with Ethics Guidelines

All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki of Declaration of 1964, as revised in 2013. Informed consent was obtained from all patients for being included in the study.

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Authors and Affiliations

  1. Department of Orthopaedics, Grant Medical College and Sir J.J. Group of Hospitals, Byculla, Mumbai, 400 007, India

    Ajay Chandanwale, Dheeraj Sonawane & Piyush Gavai

  2. B.J. Govt. Medical College, Medical College and Sassoon General Hospitals, Pune, India

    Ajay Chandanwale

  3. Grant Medical College and Sir J.J. Group of Hospitals, Byculla, Mumbai, 400 007, India

    Deepak Langade, Dheeraj Sonawane & Piyush Gavai

  4. Department of Pharmacology, Grant Medical College and Sir J.J. Group of Hospitals, Byculla, Mumbai, 400 007, India

    Deepak Langade

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  1. Ajay Chandanwale
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Correspondence to Deepak Langade.

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An erratum to this article is available at http://dx.doi.org/10.1007/s12325-017-0496-9.

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Chandanwale, A., Langade, D., Sonawane, D. et al. A Randomized, Clinical Trial to Evaluate Efficacy and Tolerability of Trypsin:Chymotrypsin as Compared to Serratiopeptidase and Trypsin:Bromelain:Rutoside in Wound Management. Adv Ther 34, 180–198 (2017). https://doi.org/10.1007/s12325-016-0444-0

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