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

NCT07148804 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2025-08-29

No results posted yet for this study

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.

Conditions

  • Diabetic Polyneuropathy

Interventions

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.

Sponsors & Collaborators

  • Helwan University

    lead OTHER

Principal Investigators

  • Ahmed Aly Massoud, PhD · Department of Hepato-gastroenterology and Infectious Diseases, Faculty of Medicine, Al-Azhar University, Cairo, Egypt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07148804 on ClinicalTrials.gov