A Study to evaluate the Safety and Efficacy of FDC of Trypsin 48 mg plus Bromelain 90 mg plus Rutoside Trihydrate 100 mg plus Diclofenac Sodium 50 mg enteric coated tablet versus Diclofenac Sodium 50 mg enteric coated tablet in patients with surgical wounds after minor surgery.
- Conditions
- Health Condition 1: null- Patients with surgical wounds after minor surgery
- Registration Number
- CTRI/2017/11/010384
- Lead Sponsor
- Macleods Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Male or female patients who are 18 to 65 years of age with surgical wounds after minor surgery.
2. Patients able to follow all study directions and commit to come at all follow-up visits as per the protocol. In addition, subjects must be willing to accept the restrictions of the study.
3. Subjects have the willingness and ability to understand and provide written informed consent to participate in the study.
1. Patients with Uncontrolled diabetes mellitus or any other metabolic disorder.
2. Patients with known hypersensitivity to any of the study related drugs.
3. Patient with hepatic and/or renal disorder, bleeding disorders, menorrhagia, hematuria and hematemesis.
4. Patients taking medicines such as tetracycline group of drugs, amoxicillin, aspirin, anticoagulants including clopidogrel should be excluded
5. Patients who are currently enrolled in another clinical investigation or have been enrolled in any surgical wound trial within a period of 30 days prior to enrollment in this study.
6. Women of child bearing age not using any contraceptive
7. Pregnant or nursing women
8. Any other condition that, in the opinion of the investigator, does not justify the inclusion of the subject in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To evaluate safety and tolerability in patients <br/ ><br>with surgical wounds after minor surgery. <br/ ><br>Incidence of adverse events and serious adverse events. <br/ ><br>Safety will be evaluated based on the adverse events reported and their plausible causal relationship with the study drug. <br/ ><br>2. Laboratory Investigations: <br/ ><br>Hematology; Biochemistry.Timepoint: For 1: Day 5, 10. <br/ ><br>For 2: Baseline, Day 10.
- Secondary Outcome Measures
Name Time Method BATES-JENSEN WOUND ASSESSMENT TOOL (BWAT) scoreTimepoint: Baseline,Day 5 and Day 10.;Number/percentage of patients with complete wound regeneration on day 5 and 10.Timepoint: Baseline,Day 5 and Day 10.;Patient and investigator global efficacy impressionTimepoint: Day 10