Clinical Research Directory

Efficacy of Topical Lidocaine Gel vs. Oral Duloxetine for Painful Diabetic Peripheral Neuropathy

Sponsor: Wah Medical college , POF hospital

Summary

The goal of this clinical trial is to learn if topical lidocaine gel can effectively reduce pain intensity compared to oral duloxetine in adult patients (aged 30-70 years) with type 2 diabetes suffering from painful diabetic peripheral neuropathy. The main questions it aims to answer are: Is there a significant difference in the reduction of pain intensity (measured by the Numeric Rating Scale) between topical lidocaine 2% gel and oral duloxetine after 8 weeks of treatment? How does the safety and tolerability profile of topical lidocaine gel compare with oral duloxetine in this patient population? Researchers will compare Group A (Topical Lidocaine 2% gel applied to the affected areas of both feet twice daily) to Group B (Oral Duloxetine 60 mg taken once daily) to see if topical lidocaine provides comparable pain relief to oral duloxetine with a reduction in systemic adverse drug reactions. Participants will: Complete a baseline clinical assessment, including nerve pain evaluation using the DN4 questionnaire and rating their pain severity on the Numeric Rating Scale (NRS). Be randomly assigned to receive either topical lidocaine 2% gel applied twice daily to both feet or oral duloxetine capsules (30 mg once daily for 2 weeks, then escalated to 60 mg once daily) for 8 consecutive weeks. Maintain their existing routine antidiabetic medications throughout the study. Attend an interim safety check visit at Week 4 to report and document any side effects or adverse drug reactions. Attend a final evaluation visit at Week 8 to record their post-treatment NRS pain score and complete safety reporting.

Official title: Comparison of the Efficacy of Topical Lidocaine Gel Versus Oral Duloxetine in the Treatment of Painful Diabetic Peripheral Neuropathy: A Prospective Randomized Controlled Trial

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