Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Levagen+

    Dietary supplement

    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

    Other intervention

    Participants will take 1 capsule twice daily with water after food. Each capsule will contain microcrystalline cellulose \[MCC\]

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Levagen+Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline to the end of the study period in overall severity of neuropathic pain

Change from baseline to the end of the study period in overall severity of neuropathic pain, as assessed by the Brief Pain Inventory Short Form for Diabetic Peripheral Neuropathy (BPI-DPN). This is a self-reported scale, higher scores indicate greater pain and interference.

Time frame
Baseline to week 12

Secondary outcomes

1

Change from baseline to the end of the study period in Neuropathic Pain Symptom Inventory

Change from baseline to the end of the study period in Neuropathic Pain Symptom Inventory (NPSI). This is a self-administered questionnaire used to evaluate neuropathic pain intensity across 5 categories, namely "superficial spontaneous pain", "deep spontaneous pain", "paroxysmal pain", "evoked pain", and "dysesthesia / paraesthesia". There are 10 pain descriptors and 2 items related to abnormal sensations. The scale ranges from 0 (no pain at all) to 10 (worst pain imaginable). The total scores of all items are combined to find the total pain intensity

Time frame
Baseline to week 12
2

Change from baseline to the end of the study period in Safety via Adverse Event reporting

Change from baseline to the end of the study period in safety via Adverse Event reporting and incident rate ratio between placebo and Levagen+

Time frame
Baseline to week 12
3

Change from baseline to the end of the study period in Safety Markers (FBC)

Change from baseline to the end of the study period in safety Markers (FBC - Full Blood Count) via blood test.

Time frame
Baseline to week 12
4

Change from baseline to the end of the study period in Safety Markers (E/LFT)

Change from baseline to the end of the study period in safety Markers (E/LFT) via blood test.

Time frame
Baseline to week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

RDC Clinical Pty Ltd

Lead sponsor

Gencor Pacific Limited, Hong Kong

Collaborator

Source ClinicalTrials.gov
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