Health Condition 1: null- PAINFUL DIABETIC NEUROPATHY
Conditions
Interventions
Intervention1: DULOXETINE: To start with, 20mg/ day for two weeks was given. In case off inadequate response, the dose was increased to 40mg/day for another 2 weeks. If pain is still not controlled, t
Sponsors
PGIMER
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion criteria 1. Presence of type 2 diabetes mellitus 2. No change in anti-diabetic medication for the last 1 month 3. Evidence of diabetic neuropathy by Diabetic Neuropathy Symptom Score >1 point, Diabetic Neuropathy Examination Score >4 point, Vibration perception test and monofilament test. 4. Neuropathic pain present for at least 1 month 5. Mean pain intensity of more than 50% by patient assessment by VAS
Exclusion criteria
Exclusion criteria: Exclusion criteria 1. Age below 18 or above 75 years 2. Evidence of renal disease (Se. creatinine > 1.5) 3. Evidence of liver disease (deranged LFT with clinical evidence) 4. Pregnant and lactating mothers and women intending pregnancy 5. Evidence of other causes for neuropathy and painful conditions 6. Epilepsy, psychiatric and cardiac diseases, hypertensives not on treatment, peripheral vascular disease and substance abuse. 7. Intake of anticonvulsants, antidepressants, membrane stabilizers and opioids 8. Participation in any other clinical trial with in the last 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients showing improvement by patient assessment of efficacy by visual analogue scale was done. This was compared between the two treatment groups.Timepoint: Baseline (0), 2,4 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of the following scores between patients for painful diabetic neuropathy- 1. Short form McGill pain questionnaire 2. 11- point Likert scale for pain 3. Hamilton rating scale for depression 4. Adverse events 5. Quality of night time sleep 6. Patient preference of the drug 7. Patient Global Impression of Change (PGIC, 7-point scale). Timepoint: baseline,2 4 6 weeks | — |
Countries
India
Contacts
Public ContactDebasish Hota
Assiociate Professor in Pharmacology
Outcome results
None listed