Health Condition 1: E084- Diabetes mellitus due to underlying condition with neurological complications
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1 Adults 18 years or more than 18 years with clinical diagnosis of diabetic polyneuropathy 2 willingness to provide informed consent and comply with study procedures
Exclusion criteria
Exclusion criteria: 1 Severe renal or hepatic impairment 2 Use of other neuropathic pain medications 3 History of substance abuse 4 Pregnancy or lactation 5 Hypersensitivity or allergy to study drugs (duloxetine, amitriptyline, and gabapentin)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcomes: oChange in Visual Analog Scale (VAS) for pain from baseline to 6 weeks oChange in burning sensation severity from baseline to 6 weeks oChange in anxiety from baseline to 6 weeks oChange in sleep disturbance from baseline to 6 weeks Timepoint: from baseline to follow up after 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcomes: o Incidence of adverse events: sedation, dizziness, edema, urinary retention, dry mouth etc. Timepoint: from baseline to follow up after 6 weeks | — |
Countries
India
Contacts
GEETANJALI MEDICAL COLLEGE AND HOSPITAL UDAIPUR