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

• Status: Not yet recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aga Khan University
• Treatments: Duloxetine Hydrochloride; Pregabalin

Criteria

Inclusion Criteria:

• Both male and female patient with age more than 18 years to 70 years.

• Patients diagnosed with peripheral neuropathic pain affected by diabetes from at least 24 weeks and all other causes off peripheral painful neuropathy has been already excluded by their primary physician.

• Patients who may agree with written inform consent.

• HbA1c ≥ 6.5% and ≤ 10%

Exclusion Criteria:

• Patients with severe hepatic disease, cardiovascular diseases, Epilepsy and respiratory diseases or any other medical or psychiatric disorders.

• Patients with uncontrolled hypertension.

• DM patients with foot ulcers, foot injuries or any other painful lesion.

• Patients who are already using or used duloxetine or pregabalin in last three month.

• Pregnant women or those who may not agree to use medical recommended birth control procedures during the treatment.

• Patient with thyroid known disorders or diagnosed during the screening

• Vitamin B12 deficient patient

• Chronic alcoholics

• DKD, with eGFR < 30ml/min

• Hypertriglycedmia (TGs more then 250mg/dl)