Biography
Biography: Amit Bhalla
Abstract
Objective: To evaluate the efficacy and safety of Topical Diclofenac with Heparin (Diclofenac sodium 1% and Heparin 200 IU w/w ) Gel in subjects with acute blunt, soft tissue injuries. Design: Open labelled, non-comparator multicenter study Setting:25 study centers in India. Participants: 296 patients with acute blunt, soft tissue injuries eg Sports injury, Sprain and Strain, frozen shoulder, knee pain, Interventions: Diclofenac with Heparin Topical Gel was applied t.i.d. for ≥48 hours and up to 7 days. Main Outcome Measures: The efficacy assessment of treatment was done based on the overall symptoms of Soft tissue Injury. The efficacy parameters for this evaluation are: Pain of movement (POM), Inflammation, Haematoma, Pain on leaning of injured limb, Oedema, Swelling, Redness and Overall pain. A 3-point scoring data was obtained for all these efficacy parameters for Baseline (BL) and End of therapy (EOT), where 0 indicates No symptoms and 3 indicates Severe symptoms. Statistical analysis: Non-parametric Wilcoxon sign rank test was applied on the data of difference between BL and EOT symptoms scores Results or Clinical Course: Patients treated with topical Diclofenac with Heparin Gel experienced significantly greater reduction in POM at EOT (p<.0001). For all injury cases, there was significant difference at 5% level of significance (p < 0.05), which gives evidence that there is significant decrease in the symptoms of Soft Tissue Injury for all the efficacy parameters. Conclusions: Diclofenac with Heparin Topical Gel applied 3 times daily was a safe and highly effective treatment for the symptoms of blunt soft tissue injuries, and it could represent a new option for the treatment of acute blunt trauma and other soft tissue injuries.