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CTRI Number  CTRI/2021/03/032053 [Registered on: 17/03/2021] Trial Registered Prospectively
Last Modified On: 19/07/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study of Trypsin, Bromelain, Rutoside and Diclofenac combination in comparison with Diclofenac to observe rapid healing of the wound and reducing pain intensity in surgery patients. 
Scientific Title of Study   An open label, multicentric, randomized, comparative clinical trial to evaluate safety and efficacy of fixed-dose combination of Trypsin 48 mg, Bromelain 90 mg, Rutoside 100 mg and Diclofenac 50 mg tablet in comparison to Diclofenac 50 mg tablet in wound management. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CT-06-07/2021  DCGI 
ZUV/PMS/FDC/TIB-D/03/2019, Version No. 4.0, dated 11.11.2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bhupesh Dewan 
Designation  Director, Medical Services 
Affiliation  Zuventus Healthcare Limited 
Address  Department of Medical Services, 3101, C Wing, Oberoi Garden Estate, Chandivali, Andheri (E) Mumbai MAHARASHTRA 400072 India

Mumbai
MAHARASHTRA
400072
India 
Phone  022-30610000  
Fax    
Email  Bhupesh.Dewan@zuventus.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bhupesh Dewan 
Designation  Director, Medical Services 
Affiliation  Zuventus Healthcare Limited 
Address  Department of Medical Services, 3101, C Wing, Oberoi Garden Estate, Chandivali, Andheri (E) Mumbai MAHARASHTRA 400072 India

Mumbai
MAHARASHTRA
400072
India 
Phone  022-30610000  
Fax    
Email  Bhupesh.Dewan@zuventus.com  
 
Details of Contact Person
Public Query  
Name  Dr Bhupesh Dewan 
Designation  Director, Medical Services 
Affiliation  Zuventus Healthcare Limited 
Address  Department of Medical Services, 3101, C Wing, Oberoi Garden Estate, Chandivali, Andheri (E) Mumbai MAHARASHTRA 400072 India

Mumbai
MAHARASHTRA
400072
India 
Phone  022-30610000  
Fax    
Email  Bhupesh.Dewan@zuventus.com  
 
Source of Monetary or Material Support  
Zuventus Healthcare Limited, 5119, D Wing, Oberoi Garden Estate, Chandivali, Andheri (E), Mumbai- 400072 
 
Primary Sponsor  
Name  Zuventus Healthcare Limited 
Address  5119, D Wing, Oberoi Garden Estate, Chandivali, Andheri (E), Mumbai- 400072 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ajay Kumar  College of Medicine & JNM Hospital  Room No. 01,Block-A, Kalyani, Nadia, West Bengal-741235, Nadia, WEST BENGAL
Nadia
WEST BENGAL 		 7003726800

drajaykr71@gmail.com 
Dr Himanshu Bansal  HB Specialty Hospital and Research Institute  Room No. 01, Department of Orthopaedics, H.B Specialty Hospital and Research Institute, Rudrapur, U.S Nagar, Uttarakhand, India-263153
Udham Singh Nagar
UTTARANCHAL 		 9897080188

hbhospital123@gmail.com 
Dr Parmesha KC  KR Hospital attached to Mysore Medical college & Research Institute  Room No:03, Department of Orthopaedics, KR Hospital, Mysore Medical College and Research Institute, Irwin Road, Mysuru, Karnataka-570001, India
Mysore
KARNATAKA 		 9343055819

parameshkennal@gmail.com 
Dr Vidhyanand Raut  Vijay Vallabh Hospital & Medical research Hospital  No. 406, Fourth Floor, Plot 423, Tirupati Nagar, Phase 1, Bolinj, Virar (West) Palghar Maharashtra - 401303 India
Thane
MAHARASHTRA 		 9823116181

vidyanandraut@rediffmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Ethics Committee HB Specialty Hospital  Approved 
Institutional Ethics Committee Mysore Medical College & Research Institute and Associated Hospitals  Approved 
Institutional Ethics Committee of College of Medicine & JNM Hospital  Approved 
Institutional Ethics Committee Vijay Vallabh Hospital and Medical Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L089||Local infection of the skin and subcutaneous tissue, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Diclofenac 50 mg tablet  1 tablet orally 3 times/day for 7 days. 
Intervention  FDC of Trypsin 48 mg, Bromelain 90 mg, Rutoside 100 mg and Diclofenac 50 mg tablet  1 tablet orally 3 times/day for 7 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients aged 18 to 65 years.
2. Patients with elective clean and uncontaminated surgery.
3. Patients willing to sign informed consent. 
 
ExclusionCriteria 
Details  1. Patients with known hypersensitivity to any of the study drugs.
2. Patients with severe renal impairment.
3. Patients with severe hepatic impairment.
4. Patients with hereditary coagulation disorder.
5. Women who are pregnant or lactating.
6. Patients with any other condition that, in the opinion of the investigator, does not justify his/her inclusion in the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Percentage of patients reporting incidences of adverse events.  Day 0 to Day 7 
 
Secondary Outcome  
Outcome  TimePoints 
Mean change in the total score of surgical wound symptoms.  Day 0 to Day 7 
Mean change in Numerical Pain Rating Scale (NPRS).  Day 0 to Day 7 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   17/03/2021 
Date of Study Completion (India) 11/09/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Wounds exhibiting impaired healing are complex wounds that fail to progress through usual phases of healing and enter a state of pathologic inflammation due to postponed, incomplete, or uncoordinated healing process. 
The oral NSAID and enzymatic composition of diclofenac, bromelain, rutoside trihydrate and trypsin is known to have analgesic, anti-inflammatory, anti-edematous and antioxidant properties. 
Trypsin has an anti-inflammatory effect due to its inhibitory action on vascular permeability. Bromelain exhibits anti-edematous, anti-inflammatory, antithrombotic and analgesic activities. Rutoside is a flavonoid compound with anti-inflammatory, anti-allergy, anti-oxidant and immunemodulating activities. Diclofenac exhibits anti-inflammatory, analgesic, and antipyretic activities. 
Therefore, this formulation along with serine and cysteine proteases is a justified combination which can be effectively used for rapid healing of wound and reducing pain intensity after surgery.
 
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