FDGL Dose-Finding Study for Diabetic Neuropathy

NCT07117942 | Completed Phase 2

• 1 other identifier: 6016
• Study Type: interventional
• Target: 485
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

FDGL; Diabetic neuropathy; Pain; Dose-finding

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale (VAS)

  The percentage improvement of diabetic neuropathy symptoms and pain scores (measured on a 0-10 scale where 0 = no pain and 10 = severe pain) at 3 months relative to baseline. This includes assessment of neuropathic complications in both lower extremities.

  Baseline, 1 month, 2 months, and 3 months

Secondary Outcomes (1)

• Incidence of adverse effects

  Throughout the 3-month study period

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Matching placebo capsules administered daily for 3 months

Drug: Fermented Deglycyrrhizinated Licorice (FDGL)

FDGL 400 mg

EXPERIMENTAL

Fermented Deglycyrrhizinated Licorice 400mg daily for 3 months

Drug: Fermented Deglycyrrhizinated Licorice (FDGL)

FDGL 800 mg

EXPERIMENTAL

Fermented Deglycyrrhizinated Licorice 800mg daily for 3 months

Drug: Fermented Deglycyrrhizinated Licorice (FDGL)

FDGL 1000 mg

EXPERIMENTAL

Fermented Deglycyrrhizinated Licorice 1000mg daily for 3 months

Drug: Fermented Deglycyrrhizinated Licorice (FDGL)

FDGL 1200 mg

EXPERIMENTAL

Fermented Deglycyrrhizinated Licorice 1200mg daily for 3 months

Drug: Fermented Deglycyrrhizinated Licorice (FDGL)

Interventions

Fermented Deglycyrrhizinated Licorice (FDGL) DRUG

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

FDGL 1000 mg; FDGL 1200 mg; FDGL 400 mg; FDGL 800 mg; Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged between 18 and 70 years
• Documented history of type I or type II diabetes mellitus
• Confirmed diagnosis of at least one diabetes-related complication, including peripheral neuropathy
• Diagnosis of peripheral neuropathy confirmed in both lower extremities
• Numeric rating scores (VAS) on 0 to 10 scale ≥ 4 for at least 6 months in feet/legs
• Ability to provide written informed consent
• If using concurrent therapies for diabetic neuropathy (pregabalin, gabapentin, or duloxetine), must be on stable doses for at least 3 months prior to study start

You may not qualify if:

• Concomitant chronic kidney disease
• Hepatic impairment
• Heart failure
• Cancer
• Major psychiatric disorders
• Pregnancy
• Refusal to sign informed consent
• Use of non-pharmacologic management strategies for diabetic neuropathy including:
• TENS (Transcutaneous Electrical Nerve Stimulation)
• Nerve block procedures
• Acupuncture
• Laser therapy

Sponsors & Collaborators

• Helwan University: lead

Study Sites (1)

Al-Azhar University

Cairo, Nasr City, 11651, Egypt

Location

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Diabetic Neuropathies; Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ahmed Aly Massoud, PhD

  Department of Hepato-gastroenterology and Infectious Diseases, Faculty of Medicine, Al-Azhar University, Cairo, Egypt

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Clinical Pharmacy

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 12, 2025
• Study Start: February 12, 2020
• Primary Completion: June 18, 2021
• Study Completion: April 10, 2023
• Last Updated: August 17, 2025

Record last verified: 2025-08

Locations

EG (1)