CTRI/2021/03/032053
Completed
Phase 4
An open label, multicentric, randomized, comparative clinical trial to evaluate safety and efficacy of fixed-dose combination of Trypsin 48 mg, Bromelain 90 mg, Rutoside 100 mg and Diclofenac 50 mg tablet in comparison to Diclofenac 50 mg tablet in wound management.
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: L089- Local infection of the skin and subcutaneous tissue, unspecified
- Sponsor
- Zuventus Healthcare Limited
- Enrollment
- 200
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients aged 18 to 65 years.
- •2\. Patients with elective clean and uncontaminated surgery.
- •3\. Patients willing to sign informed consent.
Exclusion Criteria
- •1\. Patients with known hypersensitivity to any of the study drugs.
- •2\. Patients with severe renal impairment.
- •3\. Patients with severe hepatic impairment.
- •4\. Patients with hereditary coagulation disorder.
- •5\. Women who are pregnant or lactating.
- •6\. Patients with any other condition that, in the opinion of the investigator, does not justify his/her inclusion in the study.
Outcomes
Primary Outcomes
Not specified
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