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Effect of Alpha Lipoic Acid on neuropathy symptoms and inhibition of platelet aggregation in Diabetic Neuropathy patients

A study to evaluate the effect of Alpha Lipoic acid on neuropathic symptoms and inhibition of Platelet aggregation in diabetic neuropathy patients on Gabapentin/ Pregabalin

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/10/037068
Enrollment
60
Registered
2021-10-04
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E114- Type 2 diabetes mellitus with neurological complications

Interventions

Intervention1: Alpha Lipoic Acid 600mg: Alpha Lipoic Acid 600mg once daily per oral given as add on to Gabapentin/pregabalin for 3 months Control Intervention1: Identical placebo: Identical placebo on

Sponsors

Indian Council of Medical Research
Lead Sponsor

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 or Pregabalin 75mg 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 on antiplatelet drugs 5. Patients with active cardiovascular disease 6. Patients with clinically significant skin disease 7. Pregnant and lactating women.

Design outcomes

Primary

MeasureTime frame
1.Any change in VPT values from baseline. 2. Change in the percentage inhibition of platelet aggregation from baseline Timepoint: 1.Baseline, 4weeks , 8weeks and 12weeks 2. Baseline, 4weeks ,and 12weeks—

Secondary

MeasureTime frame
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—

Countries

India

Contacts

Public ContactDr P Usha Rani

Nizams Institute of Medical Sciences

ushapingali@yahoo.com9849574143

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026