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CTRI Number  CTRI/2017/10/010004 [Registered on: 04/10/2017] Trial Registered Prospectively
Last Modified On: 08/01/2019
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 to evaluate the Safety and Effectiveness of Fixed Dose Combination of Trypsin 96 mg plus Bromelain 180 mg plus Rutoside Trihydrate 200 mg versus Trypsin - chymotrypsin (1,00,000 AU) in patients with surgical wounds after minor surgery 
Scientific Title of Study   A Multicentric, Open label, Randomized, Comparative, Clinical Study evaluating Safety and Efficacy of Fixed Dose Combination of Trypsin 96 mg plus Bromelain 180 mg plus Rutoside Trihydrate 200 mg enteric coated tablet versus Chymoral Forte (Trypsin - chymotrypsin (1,00,000 AU)) enteric coated Tablet in patients for healing potential in surgical wounds after minor surgery 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CT-187-ENZO(F)-2015 Version 03 dated 06 Jul 2017  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashish Mungantiwar 
Designation  President -Medical Services 
Affiliation  Macleods Pharmaceuticals Ltd., 
Address  Macleods Pharmaceuticals Ltd, R&D, G-2, Mahakali Caves Road, Shanti Nagar, Andheri - (East)

Mumbai
MAHARASHTRA
400 093
India 
Phone  02261132900  
Fax    
Email  drashish@macleodspharma.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashish Mungantiwar 
Designation  President -Medical Services 
Affiliation  Macleods Pharmaceuticals Ltd., 
Address  Macleods Pharmaceuticals Ltd, R&D, G-2, Mahakali Caves Road, Shanti Nagar, Andheri - (East)

Mumbai
MAHARASHTRA
400 093
India 
Phone  02261132900  
Fax    
Email  drashish@macleodspharma.com  
 
Details of Contact Person
Public Query  
Name  Mr Dinesh Garg  
Designation  Manager – Clinical Trials 
Affiliation  Macleods Pharmaceuticals Ltd., 
Address  Macleods Pharmaceuticals Ltd, R&D, G-2, Mahakali Caves Road, Shanti Nagar, Andheri - (East)

Mumbai
MAHARASHTRA
400 093
India 
Phone  02261132900  
Fax    
Email  dineshg@macleodspharma.com  
 
Source of Monetary or Material Support  
Macleods Pharmaceuticals Ltd. G-2, Mahakali Caves Road, Shanti Nagar, Andheri - (East), Mumbai – 400 093, India.  
 
Primary Sponsor  
Name  Macleods Pharmaceuticals Ltd 
Address  G-2, Mahakali Caves Road, Shanti Nagar, Andheri - (East), Mumbai – 400 093, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 13  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr G Ramesh  Anu Hospital  Department of General surgery and Gastroenterology, Anu Hospitals, Kovel amudivari Street, Suryaraopet, Vijayawada – 520002, Andhra Pradesh, India
Krishna
ANDHRA PRADESH 		 08662434855

anuhospitalscr@gmail.com 
Dr B C Shah  BhaktiVedanta Hospital & Research Institute  BhaktiVedanta Hospital & Research Institute, Srishti Complex, BhaktiVedanta Swami Marg, Mira Road (E), Thane – 401107, Maharashtra, India
Thane
MAHARASHTRA 		 9821164690
022-28459855
dr.bcshah@bhaktivedantahospital.com 
Dr Anil Luther   Christian Medical College and Hospital  Department of Surgery, Christian Medical College and Hospital Ludhiana, 141008, Punjab, India
Ludhiana
PUNJAB 		 9815995055

anilluther@yahoo.co.in 
Dr Pradeep Sharma  Inamdar multispeciality Hospital  Inamdar multispeciality Hospital, Behind KPCT Mall Fatimanagar, Pune 411040
Pune
MAHARASHTRA 		 09371016344

drpradeepsharma@gmail.com 
Dr Suresh Harbade  Ishwar Institute of Healthcare  Ishwar Heights, Plot No.7, Gut No. 6/7, Beside Punjabi Bhavan, Mumbai-Nashik Highway, Aurangabad - Maharashtra - 431002
Aurangabad
MAHARASHTRA 		 9881736351

drsharbade@gmail.com 
Dr Uday Krishna Myneni  KIMS  #1-31/1, Minister Road, Secunderabad- 500003, Telangana, India
Hyderabad
ANDHRA PRADESH 		 09949497979

myneniuday@gmail.com 
Dr Anubhav Agrawal  KRM Hospital and Research Centre   3/92-93, Vijayant Khan, Gomtinagar, Lucknow, Uttar Pradesh 226010, India
Lucknow
UTTAR PRADESH 		 07007208088

krmhrclko@gmail.com 
Dr Mohan Joshi  L.T.M.M.C. & L.T.M.G.H, Sion, Mumbai  Room no. 24, College Building, 1st floor, Dept of surgery, L.T.M.M.C. & L.T.M.G.H., Mumbai
Mumbai
MAHARASHTRA 		 9869240835

Mohansion@gmail.com 
Dr Pravin Kamble  Lifepoint Multispeciality Hospital  145/1, Mumbai Bangalore highway, Near Hotel Sayaji, Wakad, Pune-411023. Maharashtra, India.
Pune
MAHARASHTRA 		 9372074767

lpfeasibility@gmail.com 
Dr Harish Mathur  Mavens Hospital  N-37, Opposite Reliance Fresh, Vaishali Nagar, Ajmer, 305001, India
Ajmer
RAJASTHAN 		 09829279052

drharishmathur@yahoo.com 
Dr Keyur Bhatt  Nirmal Hospital Pvt. Ltd.  Nirmal Hospital Pvt. Ltd., Ring Road, Near Centre Point, Surat, Gujarat 395002, India.
Surat
GUJARAT 		 9712939693
0261-4089999
drkeyurbhatt@gmail.com 
Dr Prashant Rahate   Rahate Surgical Hospital  517, Kolbaswami Square, Juni Mangalwari, Central Avenue, Nagpur– 440008, Maharashtra, India.
Nagpur
MAHARASHTRA 		 9822464068
0712-2732266
prashantrahate84@yahoo.com 
Dr Ambarish Satwik  Sir Ganga Ram Hospital  Sir Ganga Ram Hospital Marg, Rajinder Nagar, New Delhi – 110060, India
New Delhi
DELHI 		 09810079179

asatwik@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 13  
Name of Committee  Approval Status 
ANU Hospital Ethics Committee  Approved 
Bhaktivedanta Hospital and Research Institute  Approved 
Ethics Committee Inamdar Multispeciality Hospital, Pune- Dr Pradeep Sharma  Approved 
Ethics Committee of Ishwar Institute of Healthcare, Aurangabad  Approved 
Ethics Committee, Sir Ganga Ram Hospital  Approved 
Institutional ethics committee Christian Medical College and Hospital, Ludhiana  Approved 
Institutional Ethics Committee Human Research, L.T.M.M.C. & L.T.M.G.H., Mumbai - Dr. Mohan Joshi  Approved 
Institutional Ethics Committee Rahate Surgical Hospital  Approved 
KIMS Ethics Committee  Approved 
KRM Hospital Ethics Committee  Approved 
Lifepoint research Ethics committee  Approved 
Mavens Institutional Ethics Committee  Approved 
Nirmal Hospital Pvt. Ltd. Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients with surgical wounds after minor surgery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Chymoral Forte (Trypsin - chymotrypsin (1,00,000 AU)) enteric coated Tablet  One tablet orally 3 times daily for 10 days  
Intervention  Fixed Dose Combination of Trypsin 96 mg plus Bromelain 180 mg plus Rutoside Trihydrate 200 mg enteric coated tablet  One tablet orally 3 times daily for 10 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Male or female patients who are 18 to 65 years of age with surgical wounds after minor surgery.
2.Patients able to follow all study directions and commit to come at all follow-up visits as per the protocol. In addition, subjects must be willing to accept the restrictions of the study.
3.Subjects have the willingness and ability to understand and provide written informed consent to participate in the study.
 
 
ExclusionCriteria 
Details  1.Patients with Uncontrolled diabetes mellitus or any other metabolic disorder.
2.Patients with known hypersensitivity to any of the study related drugs.
3.Patient with hepatic and/or renal disorder, bleeding disorders, menorrhagia, hematuria and hematemesis.
4.Patients taking medicines such as tetracycline group of drugs, amoxicillin, aspirin, anticoagulants including clopidogrel should be excluded.
5.Patients who are currently enrolled in another clinical investigation or have been enrolled in any surgical wound trial within a period of 30 days prior to enrollment in this study.
6.Women of child bearing age not using any contraceptive.
7.Pregnant or nursing women.
8.Any other condition that, in the opinion of the investigator, does not justify the inclusion of the subject in the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. To evaluate safety and tolerability in patients with surgical wounds after minor surgery. Incidence of adverse events and serious adverse events.
Safety will be evaluated based on the adverse events reported and their plausible causal relationship with the study drug.
2. Laboratory Investigations:
Hematology; Biochemistry.
 		 For 1: Day 5, 10.
For 2: Baseline, Day 10. 
 
Secondary Outcome  
Outcome  TimePoints 
Number/percentage of patients with complete wound regeneration on day 5 and 10
 		 Baseline,day 5, 10

 
BATES-JENSEN WOUND ASSESSMENT TOOL (BWAT) score  Baseline, day 5, 10 
Patient and investigator global efficacy impression  Day 10 
 
Target Sample Size   Total Sample Size="383"
Sample Size from India="383" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   16/10/2017 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Publication of the results of the study, whether in whole or in part, shall be within the sole and absolute discretion of Macleods Pharmaceuticals Ltd. and investigators shall not be entitled to publish any of the data or information arising during or out of the provision of the services without the prior written consent of Macleods Pharmaceuticals Ltd. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This Multicentric, Open label, Randomized, Comparative, Clinical Study will evaluate Safety and Efficacy of Fixed Dose Combination of Trypsin 96 mg + Bromelain 180 mg + Rutoside Trihydrate 200 mg enteric coated tablet versus Chymoral Forte (Trypsin - chymotrypsin (1,00,000 AU)) enteric coated tablet in patients for healing potential in surgical wounds after minor surgery.

 
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