| 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
|
|
|
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
|
|
|
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. |