At a glance
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A Multicenter, Interventional, Two-arm, Parallel-group, Randomized, Double-blinded, Placebo-controlled, Phase IV Trial to Evaluate the Efficacy of Alpha-Lipoic Acid in the Treatment of Symptomatic Diabetic Polyneuropathy in Egypt
In Brief
A Phase 4 clinical trial evaluating Alpha-Lipoic Acid (ALA) and Placebo for Polyneuropathy, Diabetic. Completed, enrolled 430 participants across 5 sites.
Detailed 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.
Study Details
Timeline
Interventions
Oral tablet
Microcrystalline cellulose (Ph 101) 427.5 mg, Magnesium stearate 71.25 mg, Sodium laurayl sulphate 6 mg, Croscarmellose sodium 11.25 mg, Silica, colloid anhydrous 11.25 mg, and Purified talc 30 mg.