CTRI/2021/07/035082
Completed
Phase 4
An open label, prospective, multicentric, randomized, controlled, comparative clinical trial to evaluate the safety and efficacy of fixed dose combination of Trypsin 48mg, Bromelain 90mg and Rutoside 100mg tablets in comparison to Trypsin: Chymotrypsin tablets with 1,00,000 armour units of enzymatic activity in wound management.
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- 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 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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