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 for 3months duration
Control Intervention1: Placebo: Identical capsule once daily per
Sponsors
Dr Kammila Sireesha
Eligibility
Inclusion criteria
Inclusion criteria: 1. Type 2 diabetic patients of either sex aged between 30 - 65 years 2. Symptomatic diabetic polyneuropathy patients with VPT value more than 15V 3. HbA1c 4. Patients on stable dose of antidiabetic drug or combination of Metformin + sulphonyl urea + DPP4 Inhibitors for the past 3 months 5. Patients on stable dose of Gabapentin 300 mg BD for past 3 months 6. Serum creatinine
Exclusion criteria
Exclusion criteria: 1. Any other conditions causing neuropathic pain 2. History of hypersensitivity to alpha Lipoic acid 3. Patients receiving other antioxidants. 4. Patients with active cardiovascular disease 5. Patients with clinically significant skin disease 6. Pregnant and lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Any change in the neuropathic symptoms assessed by NTSS 6 score between the study groups. 2. Any change in VPT values from baseline.Timepoint: baseline 4 8 and 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in quality of life between the groups 2. change in levels of NSE 3. Change in levels of MDA, NO, Glutathione and hs CRP between the groups 4. Any ADRs with study drugs. Timepoint: baseline 4 8 and 12 weeks | — |
Countries
India
Contacts
Public ContactDr P Usharani
Nizams Institute of Medical sciences
Outcome results
None listed