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

NCT ID: NCT07148804

Last Updated: 2025-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-10

Study Completion Date

2024-08-15

Brief Summary

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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

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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

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Diabetic Polyneuropathy

Keywords

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Diabetic complications Diabetic polyneuropathy Amylase deficiency Licorice FDGL

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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).

Group Type ACTIVE_COMPARATOR

Fermented Deglycyrrhizinated Licorice

Intervention Type 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).

Placebo Comparator

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

Group Type PLACEBO_COMPARATOR

Non-fermented Deglycyrrhizinated Licorice

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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).

Intervention Type DRUG

Non-fermented Deglycyrrhizinated Licorice

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

15 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Helwan University

OTHER

Sponsor Role lead

Responsible Party

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Mahmoud I Mostafa

Lecturer of Clinical Pharmacy, Faculty of Pharmacy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Aly Massoud, PhD

Role: STUDY_CHAIR

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

Locations

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Al-Azhar University

Cairo, Nasr City, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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6016A

Identifier Type: -

Identifier Source: org_study_id