A Double-Blind, Placebo-Controlled Study of Fermented Deglycyrrhizinated Licorice Extract
- Conditions
- Diabetic Polyneuropathy
- Interventions
- Drug: Fermented Deglycyrrhizinated LicoriceDietary Supplement: Non-fermented Deglycyrrhizinated Licorice
- Registration Number
- NCT07148804
- Lead Sponsor
- Helwan University
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 83
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fermented Deglycyrrhizinated Licorice 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). Placebo Comparator Non-fermented Deglycyrrhizinated Licorice 500 mg non-fermented deglycyrrhizinated licorice root extract capsules, matching FDGL in appearance, color, weight, and excipients. Administered twice daily.
- Primary Outcome Measures
Name Time Method Sensory Nerve Conduction Velocity (SCV) Baseline, 3 months, 6 months Measurement of nerve conduction velocity in sural nerve using digital electromyography equipment
- Secondary Outcome Measures
Name Time Method Vibration Perception Threshold (VPT) Baseline, 3 months, 6 months Measurement using biothesiometer at six points on each foot (big toe, metatarsal bases, instep, heel)
Sensory Nerve Action Potential Amplitude (SNAP) Baseline, 3 months, 6 months Amplitude measurement in sural nerve
Compound Muscle Action Potential Amplitude (CMAP) Baseline, 3 months, 6 months Amplitude measurement in peroneal nerve
Motor Nerve Conduction Velocity (MCV) Baseline, 3 months, 6 months Measurement of nerve conduction velocity in peroneal nerve using digital electromyography equipment
Serum α-amylase Levels Baseline, 3 months, 6 months Measurement of serum α-amylase concentration as marker of compliance and drug efficacy
Trial Locations
- Locations (1)
Al-Azhar University
🇪🇬Cairo, Nasr City, Egypt
Al-Azhar University🇪🇬Cairo, Nasr City, Egypt