Health Condition 1: M708- Other soft tissue disorders related to use, overuse and pressure
Conditions
Interventions
Control Intervention1: NIL: NIL
Sponsors
Torrent Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Male or female patients of equal to and greater than 18 years Treatment na ve patients with Orthopedic surgery General surgery and Soft tissue injuries requiring Debridement which qualify for NSAID plus oral enzyme combination at discretion of physician
Exclusion criteria
Exclusion criteria: Patients treated with gabapentanoids pregabalin gabapentin for neuropathic pain Cases with hepatic enzyme elevation of 5xULN or CKD with proteinuria greater than Stage 3 Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding) Hypersensitivity reactions (eg. Asthma rhinitis angioedema or urticaria) in response to ibuprofen aspirin or other non-steroidal anti-inflammatory drugs Uncontrolled status for congestive heart failure (NYHA II-IV) ischaemic heart disease peripheral arterial disease and/or cerebrovascular disease History of gastrointestinal bleeding or perforation related to previous NSAIDS therapy Active bleedings or bleeding disorders Hypersensitivity to trypsin-chymotrypsin paracetamol Aceclofenac or any of the other constituents Pregnancy and Lactation Patients who have any condition or medicine that in the opinion of the investigator did not the justify their inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual analogue scale (VAS) for pain, inflammation and/or swelling assessed at 24 hrs. Day 3 and Day 7 ( 2 days)Timepoint: at 24 hrs. Day 3 and Day 7 ( 2 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| Functional assessment scale score for impact on Personal care Daily activities Sleep and Affected area or limb movement assessment at 24 hrs. and Day 3 and Day 7 ( 2 days) Clinical global impression for Efficacy assessed at Day 7 ( 2 days) Clinical global impression for Tolerability assessed at Day 7 ( 2 days) hs-CRP assessment at Day 3 and 7 ( 2 days) in the overall group CBC with DLC assessment at Day 3 Safety assessment for Common Adverse events greater than 1 percentTimepoint: at 24 hrs. Day 3 and Day 7 ( 2 days) | — |
Countries
India
Contacts
Public ContactAltaf Makwana
Nanavati super speciality Hospital
Outcome results
None listed