CompletedPhase 2

A Double-Blind, Placebo-Controlled Study of Fermented Deglycyrrhizinated Licorice Extract

Egypt83 participantsStarted 2023-01-10

Plain-language summary

This double-blind, placebo-controlled study evaluated the efficacy of oral α-amylase enzyme replacement therapy in treating early-stage diabetic polyneuropathy (DPN). The study was conducted at Al-Azhar University Hospitals with 83 diabetic patients randomized to receive either fermented deglycyrrhizinated licorice extract (FDGL) containing α-amylase enzyme (2500 IU/gm) or placebo for 6 months. Primary outcomes measured improvements in nerve conduction velocity and vibration perception threshold.

Who can participate

Age range15 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Confirmed diagnosis of Type 1 or Type 2 diabetes mellitus * Age between 15 and 65 years * Diabetes duration of 1-5 years * Body Mass Index (BMI) \< 30 kg/m² * HbA1c \< 9% * Serum creatinine \< 2mg/dL * Serum α-amylase \< 45 IU/L (reference range: 28-100 IU/L) * Vibration Perception Threshold (VPT) \> 15V * Absence of clinical symptoms of diabetic polyneuropathy Exclusion Criteria: * Treatment with medications that might influence nerve function (antiepileptic agents, tricyclic antidepressants, sympathomimetic agents) * Presence of myopathies * Presence of neuropathies from other causes * Presence of malignancies * Clinical symptoms of diabetic polyneuropathy * Inability to comply with study protocol

What they're measuring

Sensory Nerve Conduction Velocity (SCV)

Timeframe: Baseline, 3 months, 6 months

Trial details

NCT IDNCT07148804

SponsorHelwan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02-01

View on ClinicalTrials.gov More Diabetic Polyneuropathy trials