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FDGL Dose-Finding Study for Diabetic Neuropathy

NCT07117942 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 485

Last updated 2025-08-17

No results posted yet for this study

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.

Conditions

  • Diabetic Neuropathy

Interventions

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

Sponsors & Collaborators

  • Helwan University

    lead OTHER

Principal Investigators

  • Ahmed Aly Massoud, PhD · Department of Hepato-gastroenterology and Infectious Diseases, Faculty of Medicine, Al-Azhar University, Cairo, Egypt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-12
Primary Completion
2021-06-18
Completion
2023-04-10

Countries

  • Egypt

Study Locations

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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 NCT07117942 on ClinicalTrials.gov