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CTRI Number  CTRI/2024/03/063636 [Registered on: 05/03/2024] Trial Registered Prospectively
Last Modified On: 11/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Post-Operative Wound care 
Scientific Title of Study   The Impact of Interventional Enzymes on Post-Operative Wound Healing - A Double-Blinded Randomized Clinical Trial. 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
MHC/CT/23-24/031 Version: 1.00 dated 28 Dec 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr V G Vaidya 
Designation  Principal Investigator 
Affiliation  Lokmanya Medical Research Centre 
Address  OPD at Fourth-floor room No.401 314 B Telco Road Chinchwad

Pune
MAHARASHTRA
411033
India 
Phone  9822057766  
Fax  -  
Email  vgvclinical@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Mrs Shilpa Risbud 
Designation  GM- Research and QA 
Affiliation  Advanced Vital Enzymes P. Ltd. (Advenza) 
Address  Unit no 424,fourth-Floor, Lodha Supremus II, Road no. 22 Wagle Industrial Estate, Thane (W)

Mumbai
MAHARASHTRA
400604
India 
Phone  2249708404  
Fax  -  
Email  shilpa@advenza.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Gayatri Ganu 
Designation  Managing Director 
Affiliation  Mprex Healthcare P. Ltd 
Address  Office at 501-514 Crossroads, Bhumkar square Wakad

Pune
MAHARASHTRA
411057
India 
Phone  8554912644  
Fax  -  
Email  drgayatri@mprex.in  
 
Source of Monetary or Material Support  
Advanced Vital Enzymes P. Ltd. (Advenza) Unit no 424,fourth-Floor, Lodha Supremus II, Road no. 22 Wagle Industrial Estate, Thane (W) Mumbai MAHARASHTRA 400604 India 
 
Primary Sponsor  
Name  Advanced Vital Enzymes P. Ltd. (Advenza) 
Address  Unit no. 424, 4th Floor, Lodha Supremus II, Road no. 22, Wagle Industrial Estate, Thane (W) - 400604, INDIA 
Type of Sponsor  Other [Nutraceutical] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr V G Vaidya  Lokmanya Medical Research Centre and Hospital  Fourth-floor OPD 401 314 B Telco Road Chinchwad
Pune
MAHARASHTRA 
9822057766
-
vgvclinical@gmail.com 
Dr Mandar Doiphode   Sangvi Multispeciality Hospital Pvt. Ltd  KRUSHNA CHOWK NEW SANGVI -411027
Pune
MAHARASHTRA 
9850077168
-
sr.feasibility@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee Sangvi Multispeciality Hospital  Approved 
Institutional Ethics Committee Lokmanya Medical Research Centre   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z481||Encounter for planned postprocedural wound closure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A: EnMax Tablet   One EnMax tablet twice a day with empty stomach followed by 240 ml of water 30 min before meal or 60 min after meal for 7 days  
Comparator Agent  Group B: Placebo Tablet   One Placebo tablet twice a day with empty stomach followed by 240 ml of water 30 min before meal or 60 min after meal for 7 Days  
Comparator Agent  Group C: Marketed Preparation  One Marketed Preparation tablet twice a day with empty stomach followed by 240 ml of water 30 min before meal or 60 min after meal for 7 Days  
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Patients with 25-50 years of age (both inclusive);
2. Patients electively posted for clean surgery (Dental surgery, Orthopaedic surgery, Cosmetic Surgery, Laparoscopic, etc.) will be included in the study;
3. Patient without any suspected or confirmed infection and receiving treatment for same;
4. Willing to give informed consent for the study.
 
 
ExclusionCriteria 
Details 
1. Allergy, sensitivity, or contraindication to any interventional product;
2. Patients undergoing emergency, clean – contaminated, contaminated and dirty surgical procedure cases;
3. Patient with hepatic and/or renal disorder, bleeding disorders, menorrhagia, hematuria and hematemesis;
4. History of gastric ulcer or bleeding diathesis;
5. Currently receiving cytotoxic therapy, or have received it within the last three months;
6. Patients treated with any investigational drug in the preceding 4 weeks;
7. Female patients with a positive pregnancy test or lactating;
8. Patients with uncontrolled diabetes mellitus or any other metabolic disorder;
9. Seriously ill and moribund patients with complications;
10. Patients unable to comply with the treatment regimen;
11. Patients with any other condition that, in the opinion of the investigator, does not justify the inclusion of the patient in the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Changes in inflammation score (edema) on VRS
2.Changes in pain score on VAS 
At day 1, 2, 5, and 7. 
 
Secondary Outcome  
Outcome  TimePoints 
The impact of investigational products on inflammatory biomarkers (ESR and CRP), analgesic requirement, and overall improvement in post-operative wound healing.
Safety of the interventions will be assessed by analyzing changes laboratory investigations, monitoring the adverse events profile and evaluating the compliance and tolerability of the investigational product throughout the study.
 
At days 1 to 7. 
 
Target Sample Size   Total Sample Size="65"
Sample Size from India="65" 
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 2 
Date of First Enrollment (India)   11/03/2024 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Surgical wounds, especially in co-morbid conditions, pose significant challenges in management. The growing use of multiple medications in healthcare highlights their relevance, yet applying them effectively in surgical wound care is comparable to "separating diamonds from the ore." Despite efforts to unravel wound molecular intricacies and explore the impact of various molecules, a definitive, evidence-based therapy for wounds remains elusive. The recent pandemic has exacerbated healthcare challenges due to limited access to facilities. In addressing clinical challenges, a clear understanding of protease enzymes is essential, offering clinicians better options for selecting appropriate drug regimens.

Thus, the aim of the study was to compare the short-term efficacy and tolerability of an oral enzyme supplement (EnMax) with the placebo and similar market product post –operative patients. The present trial was undertaken to ascertain whether oral proteolytic enzymes would act systemically to exert an anti-edema effect, thereby encouraging more rapid wound healing following surgery.

 
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