Health Condition 1: null- Diabetic Neuropathy Health Condition 2: E114- Type 2 diabetes mellitus with neurological complications
Conditions
Interventions
Intervention1: Low-dose naltrexone: Low-dose naltrexone is compared with Amitriptyline for efficacy and safety in painful diabetic neuropathy
2 mg orally once per day for a total duration of 6 weeks
Sponsors
Postgraduate Institute of Medical Education and Research
Eligibility
Inclusion criteria
Inclusion criteria: - Presence of type 2 diabetes mellitus - No change in anti-diabetic medication for the last 1 month - Evidence of diabetic neuropathy by - Diabetic Neuropathy Symptom Score >1 point - Diabetic Neuropathy Examination Score >4 point - Vibration perception test and monofilament test - Neuropathic pain present for at least 1 month. - Mean pain intensity of more than 50% by patient assessment by VAS
Exclusion criteria
Exclusion criteria: - Age below 18 or above 75 years - Evidence of renal disease (S. creatinine > 1.5) - Evidence of liver disease (deranged LFT with clinical evidence) - Pregnant and lactating mothers and women intending pregnancy. - Evidence of other causes for neuropathy and painful conditions - Epilepsy, psychiatric and cardiac diseases, hypertensives not on treatment, peripheral vascular disease and substance abuse. - Intake of anticonvulsants, antidepressants, membrane stabilizers and opioids. - Participation in any other clinical trial with in the last 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS scoring of diabetic neuropathic painTimepoint: Every 2 weeks from 2 to 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement on Likert scale, PGIC and neuropathy scoreTimepoint: every 2 weeks from 2 to 16 weeks | — |
Countries
India
Contacts
Public ContactDebasish Hota
PGIMER
Outcome results
None listed