Status:
COMPLETED
A Double-Blind, Placebo-Controlled Study of Fermented Deglycyrrhizinated Licorice Extract
Lead Sponsor:
Helwan University
Conditions:
Diabetic Polyneuropathy
Eligibility:
All Genders
15-65 years
Phase:
PHASE2
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-Azh...
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 complic...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2024
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT07148804
Start Date
January 10 2023
End Date
August 15 2024
Last Update
August 29 2025
Active Locations (1)
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1
Al-Azhar University
Cairo, Nasr City, Egypt, 11651