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Study to asses the safety and effectiveness of enzyme based pain killers in patients with closed injuries

A Multicenter, Real World Observational Study to Assess Effectiveness and Safety of Trypsin/ChymotryPsin Enzymes in PAtients With Closed Injuries(PEACE STUDY) - Peace Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/09/045523
Enrollment
450
Registered
2022-09-14
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: T148- Other injury of unspecified body region

Interventions

None listed

Sponsors

Torrent Pharmaceuticals Ltd
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: 1 Hypersensitivity to Trypsin: Chymotrypsin 2 Patients treated with gabapentanoids (pregabalin, gabapentin) for neuropathic pain

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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 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

Countries

India

Contacts

Public ContactDr Krishnaprasad K

Torrent Pharmaceuticals Ltd

KrishnaprasadKorukonda@torrentpharma.com9820806811

Outcome results

None listed

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