Levagen+ Efficacy Study on Diabetic Peripheral Neuropathy
NCT ID: NCT07028528
Last Updated: 2025-07-23
Study Results
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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RECRUITING
PHASE2
80 participants
INTERVENTIONAL
2025-07-01
2026-05-31
Brief Summary
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Participants will have remote visits and attend a local pathology centre for blood draws. They will take the study product for 12 weeks, from baseline to week 12 they will have remote visits every 3 weeks.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Levagen+
Take 1 capsule twice daily with water after food. Each capsule will contain:
A175mg containing 150 mg of palmitoylethanolamide (PEA). Total daily dose of 350mg Levagen+ containing 300 mg PEA.
Levagen+
Participants will take 1 capsule twice daily with water after food. Each capsule will contain: A175mg containing 150 mg of palmitoylethanolamide (PEA). Total daily dose of 350mg Levagen+ containing 300 mg PEA
Placebo
Take 1 capsule twice daily with water after food. Each capsule will contain microcrystalline cellulose \[MCC\].
Placebo
Participants will take 1 capsule twice daily with water after food. Each capsule will contain microcrystalline cellulose \[MCC\]
Interventions
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Levagen+
Participants will take 1 capsule twice daily with water after food. Each capsule will contain: A175mg containing 150 mg of palmitoylethanolamide (PEA). Total daily dose of 350mg Levagen+ containing 300 mg PEA
Placebo
Participants will take 1 capsule twice daily with water after food. Each capsule will contain microcrystalline cellulose \[MCC\]
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Using prescribed glucose-lowering medications, including oral medications (stable dose for 3 months or more) and/or insulin for diabetes (type 1 or 2).
* Scoring12 or more on the Self-reported Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS).
* Able to provide informed consent.
* Agree not to change current diet and/or exercise frequency or intensity during entire enrolment period.
* Agree to not participate in another clinical trial during the study period.
* Able to attend an ACL collection centre.
Exclusion Criteria
* Serious illness e.g., paraneoplastic diseases, advanced liver disease, kidney disease, hypothyroidism, mood disorders such as depression, anxiety or bipolar disorder, neurological disorders such as MS, or heart conditions, or peripheral vascular disease
* Unstable illness e.g., diabetes and thyroid gland dysfunction, hypercholesterolemia
* Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years.
* Currently taking Coumadin (Warfarin), Heparin, Dalteparin, Enoxaparin or other anticoagulation therapy including low dose aspirin
* Herbal medicines for pain relief including, but not limited to, medicinal cannabis, willow bark (Salix alba), Boswellia (Boswellia serrata) or turmeric/curcumin (Curcuma longa).
* Active smokers, nicotine use or drug (prescription or illegal substances) abuse.
* Chronic past and/or current alcohol use (\>14 alcoholic drinks per week)
* Females attempting to conceive, pregnant or lactating
* Allergic, sensitive or intolerant to any of the ingredients in active or placebo formula.
* Difficulty swallowing capsules.
* Participants who are currently participating in any other clinical trial or who have participated in any other clinical trial during the past 1 month.
* Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion.
18 Years
75 Years
ALL
No
Sponsors
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Gencor Pacific Limited
UNKNOWN
RDC Clinical Pty Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Ramasamy Venkatesh
Role: STUDY_DIRECTOR
Gencor Pacific
Locations
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RDC Clinical
Fortitude Valley, Queensland, Australia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NEULEV
Identifier Type: -
Identifier Source: org_study_id
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