FDGL Dose-Finding Study for Diabetic Neuropathy

Helwan University

Status and phase: Completed; Phase 2

Conditions: Diabetic Neuropathy

Treatments: Drug: Fermented Deglycyrrhizinated Licorice (FDGL)

Study type: Interventional

Funder types: Other

Identifiers

NCT07117942

6016

Details and patient eligibility

About

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.

Full 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.

Enrollment: 485 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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485 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Matching placebo capsules administered daily for 3 months

Treatment:

Drug: Fermented Deglycyrrhizinated Licorice (FDGL)

FDGL 400 mg

Experimental group

Description:

Fermented Deglycyrrhizinated Licorice 400mg daily for 3 months

Treatment:

Drug: Fermented Deglycyrrhizinated Licorice (FDGL)

FDGL 800 mg

Experimental group

Description:

Fermented Deglycyrrhizinated Licorice 800mg daily for 3 months

Treatment:

Drug: Fermented Deglycyrrhizinated Licorice (FDGL)

FDGL 1000 mg

Experimental group

Description:

Fermented Deglycyrrhizinated Licorice 1000mg daily for 3 months

Treatment:

Drug: Fermented Deglycyrrhizinated Licorice (FDGL)

FDGL 1200 mg

Experimental group

Description:

Fermented Deglycyrrhizinated Licorice 1200mg daily for 3 months

Treatment:

Drug: Fermented Deglycyrrhizinated Licorice (FDGL)