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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

A Prospective, Single-center, Open label, Randomized, Parallel-group, Active-controlled Clinical Study to Evaluate the Efficacy and Safety of FDC of Trypsin plus Bromelain plus Rutoside trihydrate given along with Cefuroxime axetil versus Cefuroxime axetil for Healing in Patients with Surgical Wound after Minor Surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/08/027070
Enrollment
50
Registered
2020-08-10
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L089- Local infection of the skin and subcutaneous tissue, unspecified

Interventions

Intervention1: FDC of Trypsin plus Bromelain plus Rutoside Trihydrate and Cefuroxime axetil: 1 tablet of FDC of Trypsin plus Bromelain plus Rutoside trihydrate along with 1 tablet of Cefuroxime axetil

Sponsors

Lokmanya Medical Research Center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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 page 2 / 6 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Proportion of patients with improvement in surgical wound after minor surgeryTimepoint: 11 Days—

Secondary

MeasureTime frame
Number/percentage of patients with complete wound regenerationTimepoint: on Day 5 and Day 10;Proportion of patients with improvement in surgical wound after minor surgeryTimepoint: from baseline to Day 5—

Countries

India

Contacts

Public ContactDr Sachin Onkar Khalane

Lokmanya Medical Research Center

khalanesachin@gmail.com9158071773

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026