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 range

15 Years – 65 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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