Health Condition 1: null- Patients with surgical wounds after minor surgery
Conditions
Interventions
Intervention1: Fixed Dose Combination of Trypsin 96 mg plus Bromelain 180 mg plus Rutoside Trihydrate 200 mg enteric coated tablet: One tablet orally 3 times daily for 10 days
Control Intervention1: C
Sponsors
Macleods Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To evaluate safety and tolerability in patients with surgical wounds after minor surgery. Incidence of adverse events and serious adverse events. Safety will be evaluated based on the adverse events reported and their plausible causal relationship with the study drug. 2. Laboratory Investigations: Hematology; Biochemistry. Timepoint: For 1: Day 5, 10. For 2: Baseline, Day 10. | — |
Secondary
| Measure | Time frame |
|---|---|
| BATES-JENSEN WOUND ASSESSMENT TOOL (BWAT) scoreTimepoint: Baseline, day 5, 10;Number/percentage of patients with complete wound regeneration on day 5 and 10 Timepoint: Baseline,day 5, 10 ;Patient and investigator global efficacy impressionTimepoint: Day 10 | — |
Countries
India
Contacts
Public ContactMr Dinesh Garg
Macleods Pharmaceuticals Ltd.,
Outcome results
None listed