Health Condition 1: M708- Other soft tissue disorders related to use, overuse and pressure
Conditions
Interventions
None listed
Sponsors
Torrent Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Male or female patients of greater than or equal to 18 years Treatment naïve patients with Sports injury of soft tissue injury Ankle sprain Ligament injury Knee torsion injury low back pain Trauma with fracture or fracture risk or any other injury which qualify 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| visual analogue scale VAS for pain inflammation and or swelling assessed at Baseline (Day 0) Day 5 (± 2 days) and at Day 10 (± 2 days)Timepoint: at Day 5 (± 2 days) and at Day 10 (± 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 Day 10 (± 2 days) Clinical global impression for Efficacy assessed at Day 10 (± 2 days) Clinical global impression for Tolerability assessed at Day 10 (± 2 days) hs-CRP assessment at Baseline, Day 5 (± 2 days) for cases with Soft tissue injuries and Fracture risk Safety assessment for Common Adverse events greater than 1 percent Timepoint: at Day 5 (± 2 days) and at Day 10 (± 2 days) | — |
Countries
India
Contacts
Public ContactDr Krishnaprasad K
Parimal Multispeciality Hospital
Outcome results
None listed