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Alpha Lipoic Acid for Treatment of Diabetic Neuropathy

NCT02439879 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2016-03-02

Study results available
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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%).

Conditions

  • Diabetic Neuropathy

Interventions

DRUG

Alpha lipoic acid

Alpha lipoic acid 1800 mg PO divided in 3 doses for 4 weeks . If total symptoms score decreased \>3 points patients received alpha lipoic acid 600 mg PO each day or no treatment for 16 weeks.

Sponsors & Collaborators

  • Universidad Popular Autónoma del Estado de Puebla

    lead OTHER

Principal Investigators

  • Hector Garcia-Alcala, MD · Universidad Popular Autonoma del Estado de Puebla

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2010-12-31
Completion
2010-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02439879 on ClinicalTrials.gov