Effect of Alpha Lipoic Acid on neuropathy symptoms and inhibition of platelet aggregation in Diabetic Neuropathy patients
Not Applicable
Completed
- Conditions
- Health Condition 1: E114- Type 2 diabetes mellitus with neurological complications
- Registration Number
- CTRI/2021/10/037068
- Lead Sponsor
- Indian Council of Medical Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 52
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 < 10%
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 or Pregabalin 75mg BD for past 3 months
6. Serum creatinine < 2 mg/dl.
Exclusion Criteria
1. Any other conditions causing neuropathic pain
2. History of hypersensitivity to alpha Lipoic acid
3. Patients receiving other antioxidants.
4. Patients on antiplatelet drugs
5. Patients with active cardiovascular disease
6. Patients with clinically significant skin disease
7. Pregnant and lactating women.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Any change in VPT values from baseline. <br/ ><br> <br/ ><br>2. Change in the percentage inhibition of platelet aggregation from baseline <br/ ><br>Timepoint: 1.Baseline, 4weeks , 8weeks and 12weeks <br/ ><br> <br/ ><br>2. Baseline, 4weeks ,and 12weeks
- Secondary Outcome Measures
Name Time Method 1. Any change in the neuropathic symptoms assessed by NTSS 6 score between the study groups.Timepoint: Baseline, 4weeks , 8weeks and 12weeks;2.Change in quality of life between the groupsTimepoint: Baseline, 4weeks , 8weeks and 12weeks;3.Change in levels of NSETimepoint: Baseline,12weeks;4. Change in levels of MDA, NO, Glutathione, hsCRP between the groups.Timepoint: Baseline, 4weeks, 8weeks and 12weeks;5. change in lipid profile from baselineTimepoint: Baseline, and 12weeks;6. Any ADRs with study drugs.Timepoint: Baseline, 4weeks , 8weeks and 12weeks