Phase IV Trial to Evaluate Efficacy of Alpha-Lipoic Acid in Treating Symptomatic Diabetic Polyneuropathy in Egypt
Status:
Recruiting
Trial end date:
2024-04-30
Target enrollment:
Participant gender:
Summary
The purpose of the study is to find out whether ALA is effective and safe for treating
Egyptian diabetic patients with symptomatic polyneuropathy. The ADA stated that despite the
exploration of several pharmacological therapies for DPN management, substantial evidence on
medicines that modify the natural history of DPN is still absent. This is a multicenter,
interventional, two-arm, parallel-group, randomized, double-blinded, placebo-controlled,
phase IV trial. Patients will be administered either one tablet of placebo or one tablet
containing 600 mg of ALA twice a day for 24 weeks, depending on the randomization process.