Study to asses the safety and effectiveness of enzyme based pain killers in patients with closed injuries
Not Applicable
- Conditions
- Health Condition 1: T148- Other injury of unspecified body region
- Registration Number
- CTRI/2022/09/045523
- Lead Sponsor
- Torrent Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Male or female patients 18 to 65 years
2. Newly diagnosed cases of Closed Injury
3. Patients who are treated with receiving oral trypsin:chymotrypsin (6:1) 100000 AU for at least 2
weeks in outpatient department (OPD) in routine clinical practice
4. Patients willing for follow-up at scheduled visit as per protocol at same center
Exclusion Criteria
1 Hypersensitivity to Trypsin: Chymotrypsin
2 Patients treated with gabapentanoids (pregabalin, gabapentin) for neuropathic pain
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean changes in LIKERT scale score for Stiffness, Pain and Functionality from baseline to end of 1st and 2nd week of treatmentTimepoint: baseline to end of 1st and 2nd week of treatment
- Secondary Outcome Measures
Name Time Method Change in LIKERT scale score for improvement in Functional index from baseline at the end of 1st and 2nd week of treatmentTimepoint: end of 1st and 2nd week of treatment;Change in LIKERT scale score for pain from baseline to end of 1st and 2nd week of treatmentTimepoint: end of 1st and 2nd week of treatment;Clinical Global Improvement (CGI ) of efficacy at 2nd week of therapyTimepoint: 2nd week of therapy;Composite of the change in Stiffness score at 2nd week of therapyTimepoint: 2nd week of therapy;Percentage of patients requiring 3 tablets/day of rescue medication (Acetaminophen 500 or <br/ ><br>650mg) at the end of 1st and 2nd week of therapyTimepoint: 1st and 2nd week of therapy;Safety assessment for Common Adverse events (1%)Timepoint: 1st and 2nd week of therapy