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.
- Conditions
- Local infection of the skin and subcutaneous tissue, unspecified,
- Registration Number
- CTRI/2021/03/032053
- Lead Sponsor
- Zuventus Healthcare Limited
- Brief Summary
Wounds exhibiting impaired healing are complex wounds that fail to progress through usual phases of healing and enter a state of pathologic inflammation due to postponed, incomplete, or uncoordinated healing process.
The oral NSAID and enzymatic composition of diclofenac, bromelain, rutoside trihydrate and trypsin is known to have analgesic, anti-inflammatory, anti-edematous and antioxidant properties.
Trypsin has an anti-inflammatory effect due to its inhibitory action on vascular permeability. Bromelain exhibits anti-edematous, anti-inflammatory, antithrombotic and analgesic activities. Rutoside is a flavonoid compound with anti-inflammatory, anti-allergy, anti-oxidant and immunemodulating activities. Diclofenac exhibits anti-inflammatory, analgesic, and antipyretic activities.
Therefore, this formulation along with serine and cysteine proteases is a justified combination which can be effectively used for rapid healing of wound and reducing pain intensity after surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 200
- Patients aged 18 to 65 years.
- Patients with elective clean and uncontaminated surgery.
- Patients willing to sign informed consent.
- Patients with known hypersensitivity to any of the study drugs.
- Patients with severe renal impairment.
- Patients with severe hepatic impairment.
- Patients with hereditary coagulation disorder.
- Women who are pregnant or lactating.
- 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. Day 0 to Day 7
- Secondary Outcome Measures
Name Time Method Mean change in the total score of surgical wound symptoms. Day 0 to Day 7 Mean change in Numerical Pain Rating Scale (NPRS). Day 0 to Day 7
Trial Locations
- Locations (4)
College of Medicine & JNM Hospital
🇮🇳Nadia, WEST BENGAL, India
HB Specialty Hospital and Research Institute
🇮🇳Nagar, UTTARANCHAL, India
KR Hospital attached to Mysore Medical college & Research Institute
🇮🇳Mysore, KARNATAKA, India
Vijay Vallabh Hospital & Medical research Hospital
🇮🇳Thane, MAHARASHTRA, India
College of Medicine & JNM Hospital🇮🇳Nadia, WEST BENGAL, IndiaDr Ajay KumarPrincipal investigator7003726800drajaykr71@gmail.com