NCT07148804

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

Oral α-Amylase Enzyme Replacement for the Treatment of Diabetic Polyneuropathy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Helwan University · Academic / Other
• Sex: All
• Age: 15 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

Diabetes mellitus complications continue to develop despite optimal glycemic control with insulin. Recent studies suggest that serum amylase deficiency correlates with the severity of diabetic complications. This study hypothesizes that α-amylase enzyme deficiency represents an enzymatic defect in the cascade between activated insulin receptors and mitochondrial energy liberation, contributing to diabetic complications. α-amylase is a glycolytic enzyme that undergoes entero-pancreatic circulation and is proposed to be a precursor to key phosphorylating enzymes (glycogen phosphorylase, glucokinase, and hexokinase) essential for glycolysis. Supplementation with α-amylase may restore normal carbohydrate metabolism and prevent diabetic complications. The study drug is a formulation rich in α-amylase enzyme prepared from fermented deglycyrrhizinated licorice root extract, also containing acid-lipase enzyme and naturally occurring flavonoids. The intervention was administered as 500mg capsules twice daily, one hour before meals, for 6 months alongside regular antidiabetic medications.

Conditions

• Diabetic Polyneuropathy

Interventions

Type	Name	Description
DRUG	Fermented Deglycyrrhizinated Licorice	Oral capsules containing 500 mg of fermented deglycyrrhizinated licorice root extract standardized to 2500 IU/gm of α-amylase enzyme and naturally occurring flavonoids and acid-lipase. Administered twice daily (1000 mg/day).
DIETARY_SUPPLEMENT	Non-fermented Deglycyrrhizinated Licorice	500 mg non-fermented deglycyrrhizinated licorice root extract capsules, matching FDGL in appearance, color, weight, and excipients. Administered twice daily.

Timeline

• Start date: 2023-01-10
• Primary completion: 2024-02-01
• Completion: 2024-08-15
• First posted: 2025-08-29
• Last updated: 2025-08-29

Locations

1 site across 1 country: Egypt