FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/08/072363 [Registered on: 12/08/2024] Trial Registered Prospectively
Last Modified On: 05/09/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Clinical study on investigational product for reducing inflammation after orthopedic surgery.  
Scientific Title of Study   A randomized, double-blind comparative clinical study evaluating the impact of an investigational product in managing post-operative inflammation in orthopedic surgeries. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
MHC/CT/24-25/023 Version 1.00 dated 11 July 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Hrishikesh Patkar 
Designation  Principal Investigator 
Affiliation  Ayushri Multispeciality Hospital 
Address  OPD no 1, Samadhan Chowk, Pimpri Gaon, Pimpri

Pune
MAHARASHTRA
411017
India 
Phone  9011267776  
Fax  -  
Email  sr.feasibility@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 Pvt 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 = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Hrishikesh Patkar   Ayushri Multispeciality Hospital  OPD no 1, Samadhan Chowk, Pimpari Gaon, Pimpri
Pune
MAHARASHTRA 
9011267776
-
sr.feasibility@gmail.com 
Dr Shivaji Aute  Krishna vishwa vidyapeeth Deemed to be University, karad  OPD No- 21 ground, floor Pune - Bangalore highway-4, Malkapur road karad- 415539
Satara
MAHARASHTRA 
9850827580
-
drshivajiaute@gmail.com 
Dr Ashish Suryawanshi  Lokmanya Medical Research Centre and Hospital  Fourth-floor OPD 401 314 B Telco Road Chinchwad
Pune
MAHARASHTRA 
8010347452
-
lmrc.ortho@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
IEC KIMS DEEMED TO BE UNIVERSITY KARAD  Approved 
Institutional Ethics Committee Lokmanya Medical Research Centre  Approved 
Institutional Ethics Committee Sangvi Multispeciality Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z478||Encounter for other orthopedic aftercare,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  EnMax Tablet (Proteolytic Enzymes & Rutin tablet) along with standard of care (SOC)   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 seven days along with anti inflammatory & analgesic and Antibiotic for seven to ten days.  
Comparator Agent  Marketed Preparation along with SOC   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 seven days along with Anti inflammatory & analgesic and Antibiotic of choice for seven to ten days. 
Comparator Agent  Placebo Tablet along with SOC   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 seven days along with anti inflammatory & analgesic and Antibiotic of choice for seven to ten 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 orthopedic surgery;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.Patients undergoing emergency surgery;
2.Patients receiving immunosuppressive agents;
3.Allergy, sensitivity, or contraindication to any interventional product;
4.Patient with hepatic and or renal disorder, bleeding disorders, menorrhagia, hematuria and hematemesis;
5.History of gastric ulcer or bleeding diathesis;
6.Currently receiving cytotoxic therapy, or have received it within the last three months;
7.Patients treated with any investigational drug in the preceding 4 weeks;
8.Female patients with a positive pregnancy test or lactating;
9.Patients with uncontrolled diabetes mellitus or any other metabolic disorder;
10.Seriously ill and moribund patients with complications;
11.Patients unable to comply with the treatment regimen;
12.History of use of recreational drugs within 12 months before receiving the study drugs;
13.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, Day 3, Day 6 and Day 8.
 
 
Secondary Outcome  
Outcome  TimePoints 
1.Changes in inflammatory biomarkers CRP and ESR.
2.Changes in requirement of analgesic as a rescue medication.
3.Changes in surgical wound-related symptoms score such as erythema, local irritation, discharge, induration, and tenderness based on 4-point scale.
4.Patient and physician Global Assessment of Response to Therapy score on a 5-point scale.
 
1. At Day 1 and Day 8.
2. At Day 1, Day 3, Day 6 and Day 8.
3.At Day 1, Day 3, Day 6 and Day 8.
4. At Day 8. 
 
Target Sample Size   Total Sample Size="105"
Sample Size from India="105" 
Final Enrollment numbers achieved (Total)= "105"
Final Enrollment numbers achieved (India)="105" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   19/08/2024 
Date of Study Completion (India) 21/10/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Completed 
Recruitment Status of Trial (India)  Completed 
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.

This study is crucial as effective management of post-operative inflammation in orthopedic surgeries is essential for optimizing patient recovery and reducing complications. Evaluating an investigational test product through rigorous clinical trials can potentially introduce safer and more effective treatment options. Improved inflammation control could lead to shorter hospital stays, decreased healthcare costs, and enhanced patient satisfaction. Addressing these aspects contributes significantly to advancing orthopedic surgical care and patient outcomes. 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. 

 
Close