To evaluate the effect of Alpha lipoic acid on platelet aggregation in diabetic neuropathy patients
- Conditions
- Health Condition 1: E114- Type 2 diabetes mellitus with neurological complications
- Registration Number
- CTRI/2022/02/040276
- 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
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 < 10%
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 < 2 mg/dl
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method