Efficacy and Safety of the Combination of Ten Elements for 6 Months in Patients With Diabetic Neuropathy : A Pilot Study
NCT ID: NCT05984771
Last Updated: 2023-08-09
Study Results
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Basic Information
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COMPLETED
NA
70 participants
INTERVENTIONAL
2021-01-10
2022-06-30
Brief Summary
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Detailed Description
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Patients - methods: In this pilot study, 61 patients with Diabetes Mellitus Type 2 (DMT2, 31 women), with mean duration of DM 17.5 years and mean age 63 years were randomly assigned, either to receive the combination of ten elements (2 tablets/24h) in the active group, (n=30), or the placebo (n=31) for 6 months. We used Michigan Neuropathy Screening Instrument Questionnaire and Examination (MNSIQ and MNSIE), measured vibration perception threshold (VPT) and Cardiovascular Autonomic Reflex Tests (CARTs). Nerve function was assessed by DPN Check \[sural nerve conduction velocity (SNCV) and amplitude (SNAP)\]. Sudomotor function was assessed with SUDOSCAN that measures electrochemical skin conductance in hands and feet (ESCH and ESCF). Pain (PS) questionnaire was administered, also. All patients received metformin for at least 4 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Active group
10-element combination tablet (n=30) Superoxide Dismutase (SOD, 70 UI), Palmitoylethanolamide (PEA, 300 mg) Alpha Lipoic Acid (ALA, 300 mg), vitamins B6 (1.5 mg), B1 (1.1 mg), B12 (2.5 mcg), E (7.5 mg), Nicotinamide (9 mg) and minerals (Mg 30 mg, Zn 2,5 mg) in one tablet for 6 months
Epineuron
Superoxide Dismutase (SOD, 70 UI), Palmitoylethanolamide (PEA, 300 mg) Alpha Lipoic Acid (ALA, 300 mg), vitamins B6 (1.5 mg), B1 (1.1 mg), B12 (2.5 mcg), E (7.5 mg), Nicotinamide (9 mg) and minerals (Mg 30 mg, Zn 2,5 mg) in one tablet (Epineuron)
Placebo
usual care
Placebo group
Usual care
Interventions
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Epineuron
Superoxide Dismutase (SOD, 70 UI), Palmitoylethanolamide (PEA, 300 mg) Alpha Lipoic Acid (ALA, 300 mg), vitamins B6 (1.5 mg), B1 (1.1 mg), B12 (2.5 mcg), E (7.5 mg), Nicotinamide (9 mg) and minerals (Mg 30 mg, Zn 2,5 mg) in one tablet (Epineuron)
Placebo group
Usual care
Eligibility Criteria
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Inclusion Criteria
* diabetes mellitus type 2 with diabetic neuropathy
* painful neuropathy
Exclusion Criteria
* without diabetic neuropathy
* pregant
FEMALE
No
Sponsors
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Aristotle University Of Thessaloniki
OTHER
Responsible Party
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Prof. Triantafyllos Didangelos
Professor of Internal Medicine and Diabetology
Locations
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University General Hospital AHEPA
Thessaloniki, Thessaloniki, Greece
Countries
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Other Identifiers
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54230/12.12.2020
Identifier Type: -
Identifier Source: org_study_id
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