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Clinical Trials/CTRI/2022/02/040276
CTRI/2022/02/040276
Completed
未知

A study to evaluate the effect of Alpha lipoic acid on inhibition of platelet aggregation in diabetic neuropathy patients on Gabapentin or Pregabalin

Indian council of Medical Research0 sites52 target enrollmentTBD

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Indian council of Medical Research
Enrollment
52
Status
Completed
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional

Investigators

Eligibility 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 \< 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

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.

Outcomes

Primary Outcomes

Not specified

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