Health Condition 1: E114- Type 2 diabetes mellitus with neurological complications
Conditions
Interventions
Intervention1: Duloxetine + Alpha Lipoic Acid: Participants will receive tablet Duloxetine 30 mg twice daily along with tablet Alpha lipoic acid 600 mg once daily for a duration of 6 weeks.
Control In
Sponsors
Jawaharlal Nehru Medical College and Hospital , Aligarh Muslim University
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age more than or equal to 18 years 2. Diagnosed cases of painful diabetic peripheral neuropathy involving lower limbs 3. Either sex 4. HbA1c less than or equal to 8.5% 5. Willingness to participate and provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Peripheral neuropathy due to causes other than diabetes 2. Presence of motor weakness/dysfunction in affected limb 3. Recent use of injectable corticosteroids 4. Hepatic or renal dysfunction 5. Known cervical or lumbar radiculopathy 6. History of recent trauma 7. Mental or behavioral disorders affecting participation/compliance 8. History of cerebrovascular accident (stroke) with residual deficits 9. Active infection 10. Prior treatment for diabetic neuropathy without completion of minimum 1-week washout period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Neuropathic Pain Symptom Inventory (NPSI) pain score Details: Change in NPSI total score from baseline to 6 weeks of treatment.Timepoint: Baseline,week 1,2,4,6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Nerve Conduction Study Parameters of Sural nerve and Posterior tibial nerveTimepoint: Baseline, week 6;Quality of Life using SF12 scoreTimepoint: Baseline, 6 weeks;Change in serum IL6 and TNF alpha levelsTimepoint: Baseline, 6 weeks;Incidence of adverse drug effectsTimepoint: Throughout the study duration | — |
Countries
India
Contacts
Public ContactKazi Moonfared Ahamed
Jawaharlal Nehru Medical College, Aligarh
Outcome results
None listed