Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-25 @ 5:26 PM
Study NCT ID:
NCT07148804
Status:
COMPLETED
Last Update Posted:
2025-08-29
First Post:
2025-08-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Double-Blind, Placebo-Controlled Study of Fermented Deglycyrrhizinated Licorice Extract
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003929', 'term': 'Diabetic Neuropathies'}, {'id': 'D048909', 'term': 'Diabetes Complications'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-23', 'studyFirstSubmitDate': '2025-08-11', 'studyFirstSubmitQcDate': '2025-08-23', 'lastUpdatePostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensory Nerve Conduction Velocity (SCV)', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'Measurement of nerve conduction velocity in sural nerve using digital electromyography equipment'}], 'secondaryOutcomes': [{'measure': 'Motor Nerve Conduction Velocity (MCV)', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'Measurement of nerve conduction velocity in peroneal nerve using digital electromyography equipment'}, {'measure': 'Vibration Perception Threshold (VPT)', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'Measurement using biothesiometer at six points on each foot (big toe, metatarsal bases, instep, heel)'}, {'measure': 'Serum α-amylase Levels', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'Measurement of serum α-amylase concentration as marker of compliance and drug efficacy'}, {'measure': 'Sensory Nerve Action Potential Amplitude (SNAP)', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'Amplitude measurement in sural nerve'}, {'measure': 'Compound Muscle Action Potential Amplitude (CMAP)', 'timeFrame': 'Baseline, 3 months, 6 months', 'description': 'Amplitude measurement in peroneal nerve'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diabetic complications', 'Diabetic polyneuropathy', 'Amylase deficiency', 'Licorice', 'FDGL'], 'conditions': ['Diabetic Polyneuropathy']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nα-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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of Type 1 or Type 2 diabetes mellitus\n* Age between 15 and 65 years\n* Diabetes duration of 1-5 years\n* Body Mass Index (BMI) \\< 30 kg/m²\n* HbA1c \\< 9%\n* Serum creatinine \\< 2mg/dL\n* Serum α-amylase \\< 45 IU/L (reference range: 28-100 IU/L)\n* Vibration Perception Threshold (VPT) \\> 15V\n* Absence of clinical symptoms of diabetic polyneuropathy\n\nExclusion Criteria:\n\n* Treatment with medications that might influence nerve function (antiepileptic agents, tricyclic antidepressants, sympathomimetic agents)\n* Presence of myopathies\n* Presence of neuropathies from other causes\n* Presence of malignancies\n* Clinical symptoms of diabetic polyneuropathy\n* Inability to comply with study protocol'}, 'identificationModule': {'nctId': 'NCT07148804', 'briefTitle': 'A Double-Blind, Placebo-Controlled Study of Fermented Deglycyrrhizinated Licorice Extract', 'organization': {'class': 'OTHER', 'fullName': 'Helwan University'}, 'officialTitle': 'Oral α-Amylase Enzyme Replacement for the Treatment of Diabetic Polyneuropathy', 'orgStudyIdInfo': {'id': '6016A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Fermented Deglycyrrhizinated Licorice', 'description': '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).', 'interventionNames': ['Drug: Fermented Deglycyrrhizinated Licorice']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Comparator', 'description': '500 mg non-fermented deglycyrrhizinated licorice root extract capsules, matching FDGL in appearance, color, weight, and excipients. Administered twice daily.', 'interventionNames': ['Dietary Supplement: Non-fermented Deglycyrrhizinated Licorice']}], 'interventions': [{'name': 'Fermented Deglycyrrhizinated Licorice', 'type': 'DRUG', 'description': '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).', 'armGroupLabels': ['Fermented Deglycyrrhizinated Licorice']}, {'name': 'Non-fermented Deglycyrrhizinated Licorice', 'type': 'DIETARY_SUPPLEMENT', 'description': '500 mg non-fermented deglycyrrhizinated licorice root extract capsules, matching FDGL in appearance, color, weight, and excipients. Administered twice daily.', 'armGroupLabels': ['Placebo Comparator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11651', 'city': 'Cairo', 'state': 'Nasr City', 'country': 'Egypt', 'facility': 'Al-Azhar University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Ahmed Aly Massoud, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Hepato-gastroenterology and Infectious Diseases, Faculty of Medicine, Al-Azhar University, Cairo, Egypt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helwan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Clinical Pharmacy, Faculty of Pharmacy', 'investigatorFullName': 'Mahmoud I Mostafa', 'investigatorAffiliation': 'Helwan University'}}}}