Health Condition 1: E114- Type 2 diabetes mellitus with neurological complications
Conditions
Interventions
Intervention1: Alpha lipoic acid 600mg: Alpha lipoic acid 600mg once daily per oral given as add-on to Gabapentin or Pregabalin for 3months
Control Intervention1: Identical Placebo: Identical Placebo
Sponsors
Indian council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: 1.Type 2 diabetic patients of either sex aged between 30 - 65 years 2.Duration of diabetes >10 ± 5 years 3.Symptomatic diabetic polyneuropathy patients with VPT value more than 15V 4.HbA1c 5.Patients on stable dose of antidiabetic drug or combination of Metformin + sulphonyl urea + DPP4 Inhibitors for the past 3 months 6.Patients on stable dose of Gabapentin 300 mg BD or Pregabalin 75mg BD for past 3 months 7.Serum creatinine
Exclusion criteria
Exclusion criteria: 1.Any other conditions causing neuropathic pain 2.History of hypersensitivity to alpha Lipoic acid 3.Patients on antiplatelet drugs 4.Patients receiving other antioxidants 5.Patients with active cardiovascular disease 6.Patients with liver dysfunction (ALT / AST > 3 times the upper limit of normal) 7.Patients with clinically significant skin disease 8.Pregnant and lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Any change in the percentage of inhibition of platelet aggregation from baseline. 2. Any change in VPT values from baseline. Timepoint: 1.Baseline, 4 weeks, 12 weeks 2.Baseline, 4 weeks, 8 weeks and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Any change in the neuropathic symptoms assessed by NTSS 6 score between the study groupsTimepoint: Baseline, 4 weeks, 8 weeks and 12 weeks | — |
Countries
India
Contacts
Public ContactDr P Usha Rani
Nizams Institute of Medical Sciences
Outcome results
None listed