A study of Trypsin, Bromelain, Rutoside and Diclofenac combination in comparison with Diclofenac to observe rapid healing of the wound and reducing pain intensity in surgery patients.
Phase 4
Completed
- Conditions
- Health Condition 1: L089- Local infection of the skin and subcutaneous tissue, unspecified
- Registration Number
- CTRI/2021/03/032053
- Lead Sponsor
- Zuventus Healthcare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of patients reporting incidences of adverse events.Timepoint: Day 0 to Day 7
- Secondary Outcome Measures
Name Time Method Mean change in Numerical Pain Rating Scale (NPRS).Timepoint: Day 0 to Day 7;Mean change in the total score of surgical wound symptoms.Timepoint: Day 0 to Day 7