Alpha Lipoic Acid for Treatment of Diabetic Neuropathy
Status:
Completed
Trial end date:
2010-12-01
Target enrollment:
Participant gender:
Summary
Patients with diabetic neuropathy and total symptoms score(TSS) >7 points were invited to
this open multicenter study. Patients were free of pain medications and severe diabetic
complications .Patients started alpha lipoic acid (ALA)1800 mg for 4 weeks. Patients with a
decrease >3 points in the TSS were randomly allocated to 600 mg of ALA (ALA group) or no
medications (ALA withdrawal) for 16 weeks. In each visit investigators evaluated any change
in the TSS and the necessity of rescue medication to control symptoms (mainly pain). At the
end of the study investigators compared between ALA and ALA withdrawal groups TSS levels and
the frequency of use of rescue medications. Physicians were free to manage glucose to
maintain Hba1c close to the ADA target (HbA1c <7%).
Phase:
Phase 4
Details
Lead Sponsor:
Universidad Popular Autónoma del Estado de Puebla