Health Condition 1: null- Peripheral diabetic neuropathy
Conditions
Interventions
Intervention1: Gabapentin: 300-600mg od/bd for 12 weeks
Intervention2: pregabalin: 75mg-300mg, daily od/bd
12 weeks
Intervention3: Duloxetine: 20-80 mg daily od/bd
12 weeks
Control Intervention1: Nil: Nil
Sponsors
Research society for the study of diabetes in India RSSDI
Eligibility
Inclusion criteria
Inclusion criteria: Either gender with type 2 diabetes b/w 5-10 yrs duration Patients with distal polyneuropathy by history, examination, biothesiometry & Michigan Neuropathy Screening Instrument (MNSI) Diabetic neuropathy (DN) for at least 3 months Patients above 18 and below 65 years HbA1C Minimum VAS score for pain of 40 mm Patients with written informed consent
Exclusion criteria
Exclusion criteria: Contraindications for the use of study drugs. Hepatic, cardiac or renal failure Patients with neuropathy due to other causes. Patients who have undergone amputations of even one lower limb. Pregnant and lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy measure: Reduction in pain scores at the end of 12 weeks from base line using VAS(100mm). Timepoint: 0,4,8,12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary efficacy measures: Sleep interference: 10 point scale (0-10). Patient Global Impression of Change (PGIC)(0-7) Clinician?s Global Impression of Change (CGIC)(0-7) Timepoint: 0,4,8,12 weeks | — |
Countries
India
Contacts
Public ContactPadmini devi
Outcome results
None listed