FDGL Dose-Finding Study for Diabetic Neuropathy

Summary

This study investigates the optimal dose of fermented deglycyrrhizinated licorice (FDGL) that maximizes both safety and efficacy in managing diabetic neuropathy complications in adults. The study is a single-center, double-blind, parallel, placebo-controlled randomized clinical trial where patients with diabetic neuropathy are randomized to receive placebo, 400 mg, 800 mg, 1000 mg, or 1200 mg daily doses of FDGL for three months. The primary objective is to determine the percentage improvement of diabetic neuropathy presentations and pain scores at three months relative to baseline.

Timeline

Start

2020-02-12

Primary completion

2021-06-18

Completion

2023-04-10

Publications

• Background Massoud A, Ebiary FHE, Raafat M, et al. The Effect of Fermented Deglycyrrhizinized Liquorice Extract on the Structure of Gastrocnemius Muscle and Sciatic Nerve in Experimentally Induced Diabetes Mellitus in Rats: Histopathological Study. J Cytol Histol 2019;10:1-8.

Drugs

Indications