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

NCT07148804 | Completed Phase 2

• 1 other identifier: 6016A
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Diabetic complications; Diabetic polyneuropathy; Amylase deficiency; Licorice; FDGL

Outcome Measures

Primary Outcomes (1)

• Sensory Nerve Conduction Velocity (SCV)

  Measurement of nerve conduction velocity in sural nerve using digital electromyography equipment

  Baseline, 3 months, 6 months

Secondary Outcomes (5)

• Motor Nerve Conduction Velocity (MCV)

  Baseline, 3 months, 6 months

• Vibration Perception Threshold (VPT)

  Baseline, 3 months, 6 months

• Serum α-amylase Levels

  Baseline, 3 months, 6 months

• Sensory Nerve Action Potential Amplitude (SNAP)

  Baseline, 3 months, 6 months

• Compound Muscle Action Potential Amplitude (CMAP)

  Baseline, 3 months, 6 months

Study Arms (2)

Fermented Deglycyrrhizinated Licorice

ACTIVE COMPARATOR

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).

Drug: Fermented Deglycyrrhizinated Licorice

Placebo Comparator

PLACEBO COMPARATOR

500 mg non-fermented deglycyrrhizinated licorice root extract capsules, matching FDGL in appearance, color, weight, and excipients. Administered twice daily.

Dietary Supplement: Non-fermented Deglycyrrhizinated Licorice

Interventions

Fermented Deglycyrrhizinated Licorice DRUG

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).

Fermented Deglycyrrhizinated Licorice

Non-fermented Deglycyrrhizinated Licorice DIETARY_SUPPLEMENT

500 mg non-fermented deglycyrrhizinated licorice root extract capsules, matching FDGL in appearance, color, weight, and excipients. Administered twice daily.

Placebo Comparator

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Helwan University: lead

Study Sites (1)

Al-Azhar University

Cairo, Nasr City, 11651, Egypt

Location

MeSH Terms

Conditions

Diabetic Neuropathies; Diabetes Complications

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Ahmed Aly Massoud, PhD

  Department of Hepato-gastroenterology and Infectious Diseases, Faculty of Medicine, Al-Azhar University, Cairo, Egypt

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Clinical Pharmacy, Faculty of Pharmacy

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 29, 2025
• Study Start: January 10, 2023
• Primary Completion: February 1, 2024
• Study Completion: August 15, 2024
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)