Health Condition 1: E114- Type 2 diabetes mellitus with neurological complications
Conditions
Interventions
Intervention1: Duloxetine: Duloxetine 60 mg daily for 12 weeks
Control Intervention1: Gabapentine: Gabapentine 300 mg daily for 12 weeks
Sponsors
All India Institute of Medical Sciences Jodhpur
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either sex with type 2 DM, aged 18 -75 years, who were on stable glucose-lowering medications during the preceding month and who had Painful diabetic neuropathy for at least1 month. 2.Had a pain score of >50%, as assessed by visual analog scale (VAS).
Exclusion criteria
Exclusion criteria: 1.If they had any clinically significant or unstable medical or psychiatric illnesses. 2.Patients with other causes of neuropathy. 3.Renal dysfunction; liver disease; epilepsy; psychiatric illness; uncontrolled hypertension; malignancy; 4.Substance abuse; those taking anticonvulsants, antidepressants, local anaesthetics, or opioids; 5.Pregnant; lactating women; or those being treated with any investigational drug within last 30 days. 6.If they had Vitamin B12 level less than 200 pg/ml. 7.Patients with HbA1C levels > 9 %.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the efficacy of Duloxetine versus Gabapentin in patients with painful diabetic neuropathy in terms of Visual Analogue Scale (VAS).Timepoint: 0, 6, 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the change in diabetic neuropathy symptom (DNS) score, diabetic neuropathy examination (DNE) score and modified neuropathy symptom score (NSS) of Duloxetine versus Gabapentin in patients with painful diabetic neuropathyTimepoint: 0, 6 and 12 weeks;To compare the safety of Duloxetine versus Gabapentin in patients with painful diabetic neuropathy.Timepoint: Throughout the study | — |
Countries
India
Contacts
Public ContactDr Sameer Khasbage
All India Institute of Medical Sciences Jodhpur
Outcome results
None listed