title: A Randomized, Clinical Trial to Evaluate Efficacy and Tolerability of Trypsin:Chymotrypsin as Compared to Serratiopeptidase and Trypsin:Bromelain:Rutoside in Wound Management.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  Clinical Trial Registry of India (Reg. No. CTRI/2011/07/001920).
authors.affiliation: Department of Orthopaedics, Grant Medical College and Sir J.J. Group of Hospitals, Byculla, Mumbai, 400 007, India.|B.J. Govt. Medical College, Medical College and Sassoon General Hospitals, Pune, India.
authors.forename: Ajay
authors.initials: A
authors.lastname: Chandanwale
authors.affiliation: Grant Medical College and Sir J.J. Group of Hospitals, Byculla, Mumbai, 400 007, India. drdgl@hotmail.com.|Department of Pharmacology, Grant Medical College and Sir J.J. Group of Hospitals, Byculla, Mumbai, 400 007, India. drdgl@hotmail.com.
authors.forename: Deepak
authors.identifier: http://orcid.org/0000-0001-8382-5216
authors.initials: D
authors.lastname: Langade
authors.affiliation: Department of Orthopaedics, Grant Medical College and Sir J.J. Group of Hospitals, Byculla, Mumbai, 400 007, India.|Grant Medical College and Sir J.J. Group of Hospitals, Byculla, Mumbai, 400 007, India.
authors.forename: Dheeraj
authors.initials: D
authors.lastname: Sonawane
authors.affiliation: Department of Orthopaedics, Grant Medical College and Sir J.J. Group of Hospitals, Byculla, Mumbai, 400 007, India.|Grant Medical College and Sir J.J. Group of Hospitals, Byculla, Mumbai, 400 007, India.
authors.forename: Piyush
authors.initials: P
authors.lastname: Gavai
mesh_terms: D000328:Adult; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D001963:Bromelains / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002918:Chymotrypsin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D004890:Erythema / Q000188:drug therapy; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010447:Peptide Hydrolases / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D012431:Rutin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D014357:Trypsin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D014945:Wound Healing / Q000187:drug effects; D014947:Wounds and Injuries / Q000188:drug therapy*
chemical_list: D000893:Anti-Inflammatory Agents; D004338:Drug Combinations; D012431:Rutin; C007059:chymotrypsin, trypsin drug combination; D001963:Bromelains; D010447:Peptide Hydrolases; D002918:Chymotrypsin; D014357:Trypsin; C022640:serratiopeptidase
keywords: Bromelain; Chymotrypsin; Orthopedic surgery; Proteinase enzymes; Rutoside; Serratiopeptidase; Trypsin; Wound Healing