Levagen+ Efficacy Study on Diabetic Peripheral Neuropathy
ConditionDiabetic Peripheral Neuropathy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRDC Clinical Pty Ltd
About this trial
The goal of this clinical trial is to assess the efficacy of Levagen+ supplementation for the symptoms of diabetic peripheral neuropathy (DPN) in patients with DPN.
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.
Eligibility criteria
Qualifiers
Adults aged 18-75 years.
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.
Disqualifiers
Peripheral neuropathy due to causes other than diabetes mellitus (e.g. nutritional deficiencies; hereditary sensory neuropathy; paraneoplastic diseases; advanced liver disease; kidney disease; hypothyroidism; prolonged phenytoin, warfarin or immunosuppressive drug use; active infection [HIV, Lyme disease, Epstein-Barr virus, Hepatitis C, Shingles, Leprosy]; autoimmune disease [Sjogren syndrome, Lupus, Rheumatoid arthritis, Guillain-Barre syndrome]; trauma / injury; toxins [heavy metals, chemicals]; antibiotics; or inflammatory conditions [vasculitis]).
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.
Trial design
Treatments tested in this trial
- Levagen+
- Placebo
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
RDC Clinical Pty Ltd
Lead sponsor
Gencor Pacific Limited, Hong Kong
Collaborator
Source ClinicalTrials.gov