Health Condition 1: Z478- Encounter for other orthopedic aftercare
Conditions
Interventions
Intervention1: 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
Sponsors
Advanced Vital Enzymes P. Ltd. (Advenza)
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Changes in inflammation score (edema) on VRS. 2.Changes in pain score on VAS. Timepoint: At Day 1, Day 3, Day 6 and Day 8. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. Timepoint: 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. | — |
Countries
India
Contacts
Public ContactDr Gayatri Ganu
Advanced Vital Enzymes P. Ltd. (Advenza)
Outcome results
None listed