Health Condition 1: G63- Polyneuropathy in diseases classified elsewhere
Conditions
Interventions
Intervention1: Duloxetine: Tablet Duloxetine 30mg twice daily orally for 8 weeks
Control Intervention1: Gabapentin: Tablet Gabapentin 300mg once daily orally for 8 weeks
Sponsors
NIL
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of 18 to 65 years of either gender 2. Patients diagnosed with diabetic peripheral polyneuropathy by clinical examination and are not on any medication for DPNP 3. Patients with time frame of Diabetes diagnosis was between 5 to 15 years 4. Patients HbA1c level is between 5% to 10% 5. Patients willing to give written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients who were contraindicated from the use of duloxetine or gabapentin 2. Pregnant or lactating women 3. Patients are alcohol abusers or drug addicts 4. Patients with amputation in their lower limb 5. Patients with alcohol associated neuropathy, Nutritional linked neuropathy, Uremic neuropathy and Vitamin B-12 deficiency 6. Patients on any other concomitant medication for pain management
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference In mean scores of Visual analogue scale (VAS) in patients receiving Duloxetine and Gabapentin, from baseline to the end of 8 weeksTimepoint: Baseline, 4 weeks, 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events reported by patients receiving Duloxetine & Gabapentin by patients reported adverse events at the end of 8 weeksTimepoint: Baseline, 4 weeks, 8 weeks;Difference in mean scores of WHOQOL-BREF (WHO Quality of life brief version) scale in patients receiving Duloxetine & Gabapentin from baseline to end of 8 weeksTimepoint: Baseline, 4 weeks, 8 weeks | — |
Countries
India
Contacts
Public ContactKAMARAPU SRAVAN
GMC, Nagpur
Outcome results
None listed