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Study on safety and effectiveness, and usage of Trypsin:chymotrypsin

A post approval observational study to assess the impact of fixed dose combination of Trypsin: Chymotrypsin Plus Aceclofenac Plus Paracetamol) in acute inflammatory painful conditions (COMBORELIEF) - COMBORELIEF

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/02/080204
Enrollment
3000
Registered
2025-02-10
Start date
Unknown
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Health Condition 1: 8- Other Procedures

Interventions

Intervention1: Nil: Not Appliable Control Intervention1: NIl: Not Applicable

Sponsors

Torrent Pharmaceuticals Ltd.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female patients 18 years or above 2. Clinical cases of soft tissue, traumatic or sports injuries 3. Patients willing for follow-up at scheduled visit as per protocol at same center.

Exclusion criteria

Exclusion criteria: Hypersensitivity to trypsin-chymotrypsin or paracetamol or Aceclofenac or any of the other constituents. 2. Patients treated with gabapentanoids (pregabalin, gabapentin) for neuropathic pain 3. Severe liver problems, kidney impairment, peptic ulcer, high vitreous pressure Active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding) 5. Hypersensitivity reactions (eg. Asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin, or other non-steroidal anti-inflammatory drugs 6. Established congestive heart failure (NYHA II-IV), ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease. 7. History of gastrointestinal bleeding or perforation, related to previous NSAIDS therapy. 8. Active bleedings or bleeding disorders.

Design outcomes

Primary

MeasureTime frame
Mean change in visual analogue scale at the end of the treatmentTimepoint: at 1 week

Secondary

MeasureTime frame
Patient and physician Global impression at the end of the treatmentTimepoint: at 1 week

Countries

India

Contacts

Public ContactDr Krishnaprasad K MD

Torrent Pharmaceuticals Ltd.

PratikRPatel@torrentpharma.com7069000560

Outcome results

None listed

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