drugset / Trial / NCT07148804

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

NCT07148804 ↗

Phase 2 Completed 83 enrolled Helwan University
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2023-01-10
Primary completion
2024-02-01
Completion
2024-08-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fermented Deglycyrrhizinated Licorice Unknown 500 mg Oral