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NCT07148804

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

Completed Phase 2 Last updated 29 August 2025
What this trial tests

Phase 2 trial testing Fermented Deglycyrrhizinated Licorice in Diabetic Polyneuropathy in 83 participants. Completed in 15 August 2024.

Timeline
10 January 2023
Primary endpoint
1 February 2024
15 August 2024

Quick facts

Lead sponsorHelwan University
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment83
Start date10 January 2023
Primary completion1 February 2024
Estimated completion15 August 2024
Sites1 location across Egypt

Drugs / interventions tested

Conditions studied

Sponsor

Helwan University

Who can join

Adults 15 to 65, any sex, with Diabetic Polyneuropathy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Randomized Double-blind Placebo-controlled study to evaluate the efficacy of fermented deglycyrrhizinated licorice for treatment of diabetic polyneuropathy.
    Massoud AMA, Massoud HMA, El-Shawarby AA, Elseidy MI. · · 2026 · PMID 41627541 · DOI 10.1007/s12020-025-04476-5

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Other recruiting trials for Diabetic Polyneuropathy

Currently open trials in the same condition.

Other Helwan University trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07148804.

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