Clinical study on investigational product for reducing inflammation after orthopedic surgery.

Phase 2

Conditions: Health Condition 1: Z478- Encounter for other orthopedic aftercare

Registration Number: CTRI/2024/08/072363

Lead Sponsor: Advanced Vital Enzymes P. Ltd. (Advenza)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Changes in inflammation score (edema) on VRS. <br/ ><br>2.Changes in pain score on VAS. <br/ ><br>Timepoint: At Day 1, Day 3, Day 6 and Day 8. <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1.Changes in inflammatory biomarkers CRP and ESR. <br/ ><br>2.Changes in requirement of analgesic as a rescue medication. <br/ ><br>3.Changes in surgical wound-related symptoms score such as erythema, local irritation, discharge, induration, and tenderness based on 4-point scale. <br/ ><br>4.Patient and physician Global Assessment of Response to Therapy score on a 5-point scale. <br/ ><br>Timepoint: 1. At Day 1 and Day 8. <br/ ><br>2. At Day 1, Day 3, Day 6 and Day 8. <br/ ><br>3.At Day 1, Day 3, Day 6 and Day 8. <br/ ><br>4. At Day 8.