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To assess the safety and effectiveness of oral enzymes (Trypsin:Chymotrypsin)

A Post appRoval observational study to assess the safety and efficacy of oral proteolytic ENZYMEs (Trypsin:Chymotrypsin) in outpatients settings of India (PRO-ENZYME) - PRO-ENZYME

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/10/075660
Enrollment
8000
Registered
2024-10-23
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-11

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

Intervention1: Nil: NA Control Intervention1: Nil: NA

Sponsors

Torrent Pharmaceuticals Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female patients of =18 years 2. Clinical cases of soft-tissue, traumatic, sport injuries or post-operative injuries 3. 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 3. Patients with severe liver, kidney impairment, peptic ulcer, high vitreous pressure, and hypersensitivity

Design outcomes

Primary

MeasureTime frame
Mean change in Visual Analogue Scale (VAS) for pain at the end of first follow up visitTimepoint: Baseline and week 1—

Secondary

MeasureTime frame
Patient and Physician Global impression at the end of first follow up visitTimepoint: Baseline and week 1;Safety assessment for Common Adverse eventsTimepoint: Baseline and week 2—

Countries

India

Contacts

Public ContactDr Krishnaprasad K MD

Torrent Pharmaceuticals Ltd.

PratikRPatel@torrentpharma.com9654868678

Outcome results

None listed

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