drugset / Trial / NCT05292066

Efficacy of Pregabalin Vs Duloxetine in Diabetic Peripheral Neuropathic Pain at Variable Dose

NCT05292066

Phase 0 Unknown 126 enrolled Aga Khan University
RandomizedParallel-groupOpen-labelSupportive care

Summary

Background Diabetic neuropathy is a widespread, debilitating condition and its management needs a significant cost. Around, 50% of diabetes mellitus (DM) patients suffer from Diabetic Peripheral Neuropathic Pain (DPNP). According to the reported data, specific anticonvulsants and antidepressants are effective for coping diabetic peripheral neuropathy. Two drugs, duloxetine and pregabalin, are officially permitted by the Food and Drug Administration (FDA) for the management of DPNP. Methodology A Prospective Randomized Controlled Trial (RCT) trial for 12 weeks will be carried out on 126 volunteer DPNP patients with age between 18- to 70-year-old and participants was selected through consecutive sampling and will be evaluated on the basis of duration of the disease, pain scales and the data provided by particular consultants. The parameters will be measured weekly and final parameters will be measured after 12 weeks. Statistical analysis will be carried out by SPSS, ANOVA, and t-test. Expected outcomes: From this experimental design, investigators are expecting improvement in the management of DPNP and Duloxetine is more effective for treating patients suffering from DPNP.

Timeline

Start
2022-10
Primary completion
2022-12
Completion
2022-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Duloxetine Small molecule 30 mg Oral
Subject Pregabalin Small molecule 75 mg Oral

Indications