Post-Operative Wound care

The Impact of Interventional Enzymes on Post-Operative Wound Healing - A Double-Blinded Randomized Clinical Trial. - NA

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/063636

Enrollment

Registered

2024-03-05

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Z481- Encounter for planned postprocedural wound closure

Interventions

Intervention1: 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 Control Intervention1: Group B: Pla

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
1.Changes in inflammation score (edema) on VRS 2.Changes in pain score on VASTimepoint: At day 1, 2, 5, and 7.	—

Secondary

Measure	Time frame
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. Timepoint: At days 1 to 7.	—

Measure

Time frame

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. Timepoint: At days 1 to 7.

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Countries

India

Contacts

Public ContactDr Gayatri Ganu

Advanced Vital Enzymes P. Ltd. (Advenza)

shilpa@advenza.co.in2249708404

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026