| 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
|
|
|
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
|
|
|
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. |