Study to compare efficacy and safety of trypsion plus bromelain plus rutoside tablet along with cefuroxime axetil tablet versus cefuroxime axetil tablet given alone in patients with surgical wound after minor surgery
- Conditions
- Health Condition 1: L089- Local infection of the skin and subcutaneous tissue, unspecified
- Registration Number
- CTRI/2020/08/027070
- Lead Sponsor
- okmanya Medical Research Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Adult male or female patients aged between 18 to 65 years of age
(both ages inclusive)
2. Diagnosed with surgical wounds after minor surgery mainly
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REF/2020/06/034654
CTRI Website URL - http://ctri.nic.in
involving skin and skin
structure infections
3. Women of childbearing potential must be willing to consistently
use an appropriate
method of contraception
4. Willingness to give their written informed consent to participate in
the study
5. Is willing to comply with all aspects of the protocol
1. Patients with known hypersensitivity to active ingredients or
inactive ingredients of the
study treatment or other ?-lactams (e.g., penicillins and
cephalosporins) except study
treatment.
2. Female patients who are pregnant or lactating or planning to be
pregnant.
3. Patients with known history of clostridium difficile-associated
diarrhea.
4. Patients receiving medicines such as tetracycline group of drugs,
amoxicillin, aspirin, and
anticoagulants including clopidogrel.
5. Currently receiving treatment with IP or systemic or topical
antibiotics or systemic
therapy with cytotoxic drugs.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients with improvement in <br/ ><br>surgical wound after minor surgeryTimepoint: 11 Days
- Secondary Outcome Measures
Name Time Method umber/percentage of patients with complete <br/ ><br>wound regenerationTimepoint: on Day 5 and Day 10;Proportion of patients with improvement in <br/ ><br>surgical wound after minor surgeryTimepoint: from baseline to Day 5