EUROPEAN JOURNAL OF
PHARMACEUTICAL AND MEDICAL RESEARCH

( An ISO 9001:2015 Certified International Journal )

An International Peer Reviewed Journal for Pharmaceutical, Medical & Biological Sciences

An Official Publication of Society for Advance Healthcare Research (Reg. No. : 01/01/01/31674/16)

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 ISSN 2394-3211

Impact Factor: 6.222

 ICV - 79.57

Abstract

SYSTEMIC ENZYME THERAPY WITH TRYPSIN-BROMELAIN-RUTOSIDE COMBINATION TO COUNTER POST-OPERATIVE WOUND INFLAMMATION – A RANDOMISED ACTIVE-CONTROLLED MULTICENTRE TRIAL

Girish D Bakhshi, Shashank Tiwari, Rajesh Kumar Prajapati, Girish H Rudrappa, Mrutyunjay I. Uppin*, Pratik J Vinchhi, Shrihari A Dhorepatil, Hemant L Dhusia, Gautam V Daftary, Ganesh H Divekar, James John and Pratik P Wadivkar

ABSTRACT

Background: Systemic enzyme therapy with combination of Trypsin, Bromelain and Rutoside is used worldwide to control inflammation and speed-up healing process. The combination is available in India in two formulations – a dispersible tablet form and a solid enteric-coated tablet form. The inflammation and tissue repair associated with post-operative wounds are expected to benefit from such therapy. Aim: To assess the impact of two formulations of Trypsin-Bromelain-Rutoside (TBR) against that of Serratiopeptidase on postoperative clinical markers of local (wound) inflammation. Materials and Methods: This study was designed as randomised, parallel group, comparative, 3-arm, multicentre, assessor-blind, active-controlled trial. Eligible subjects were randomised to one of the three groups – Group 1 (enteric-coated TBR), Group 2 (dispersible TBR) or Group 3 (Serratiopeptidase). The efficacy assessments were based on scores of post-operative swelling and pain and improvement in subjects’ and investigators’ global assessment. The data from the groups were compared using Chi-square test. Results: 309 subjects were enrolled in the study. Significantly (p<0.05) higher proportion of subjects in both Groups 1 and 2 reported none/mild swelling and no/mild pain on postoperative days 3 and 8, compared to Group 3. The incidence of subject-reported and investigator-reported global assessment scores indicating good to excellent pain relief and swelling reduction, on postoperative days 3 and 8, were also significantly (p<0.05) higher with Groups 1 and 2. Fewer subjects in Groups 1 and 2 required rescue medication. Conclusion: Systemic enzyme therapy with Trypsin-Bromelain-Rutoside provided significantly better control and resolution of post-operative pain and inflammation, compared to Serratiopeptidase.

Keywords: Bromelain, rutoside, trypsin, surgery, inflammation, proteases.


[Full Text Article]

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Google Scholar Indian Science Publications InfoBase Index (In Process) SOCOLAR, China Research Bible, Fuchu, Tokyo. JAPAN International Society for Research activity (ISRA) Scientific Indexing Services (SIS) Polish Scholarly Bibliography Global Impact Factor (GIF) (Under Process) Universal Impact Factor International Scientific Indexing (ISI), UAE Index Copernicus CAS (A Division of American Chemical Society) USA (Under Process) Directory of Open Access Journal (DOAJ, Sweden, in process) UDLedge Science Citation Index CiteFactor Directory Of Research Journal Indexing (DRJI) Indian citation Index (ICI) Journal Index (JI, Under Process) Directory of abstract indexing for Journals (DAIJ) Open Access Journals (Under Process) Impact Factor Services For International Journals (IFSIJ) Cosmos Impact Factor Jour Informatics (Under Process) Eurasian Scientific Journal Index (ESJI) International Innovative Journal Impact Factor (IIJIF) Science Library Index, Dubai, United Arab Emirates Pubmed Database [NLM ID: 101669306] (Under Process) IP Indexing (IP Value 2.40) Web of Science Group (Under Process) Directory of Research Journals Indexing Scholar Article Journal Index (SAJI) International Scientific Indexing ( ISI )