NCT07117942

FDGL Dose-Finding Study for Diabetic Neuropathy

The Efficacy and Safety of Different Doses of Fermented Deglycyrrhizinated Licorice (FDGL) in the Management of Diabetic Neuropathy: A Randomized Controlled Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 485 (actual)
• Sponsor: Helwan University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a single-center, double-blinded, parallel, randomized clinical trial conducted at Al-Hussein University Hospital, Cairo, Egypt. Eligible patients are randomized to receive either placebo, 400 mg, 800 mg, 1000 mg, or 1200 mg daily FDGL doses in a 1:1:1:1:1 ratio using block randomization with a block size of 5. The study employs computer-assisted random number generation for treatment allocation. Both patients and nurses are blinded to treatment allocation, with assignments kept in sealed envelopes opened only at enrollment. The study duration is 3 months with follow-up assessments at 1, 2, and 3 months.

Conditions

• Diabetic Neuropathy

Interventions

Type	Name	Description
DRUG	Fermented Deglycyrrhizinated Licorice (FDGL)	Fermented Deglycyrrhizinated Licorice (FDGL) in oral powder capsules; prepared through three consecutive steps: fermentation of licorice roots, removal of glycyrrhizinic acid content (deglycyrrhizination), and lyophilization according to EUROPEAN PATENT SPECIFICATION Ep 1 925 312 B

Timeline

• Start date: 2020-02-12
• Primary completion: 2021-06-18
• Completion: 2023-04-10
• First posted: 2025-08-12
• Last updated: 2025-08-17

Locations

1 site across 1 country: Egypt