None listed
Conditions
Brief summary
The aim of the study is to determine if Palmitoylethanolamide can reduce diabetic induced neuropathic pain and inflammation over a 8 week period. The study is a randomised clinical trial comparing Palmitoylethanolamide (active treatment) with a control (placeb0). The active treatment is a 350mg capsule taken twice daily (total 700mg/day) for 8 weeks. The outcomes being evaluated in the study are: the severity of neuropathic pain and the characteristics of the neuropathic pain, the effect of the neuropathic pain on quality of life, the use of rescue medications used during the study and the effect of the active treatment on general health pathology and inflammation markers.
Interventions
Palmitoylethanolamide
LevagenTM+ Palmitoylethanolamide 350mg capsules
Taken twice a day (morning and evening) for 8 weeks
Adherence to the intervention will be monitored by clinical staff at interviews and by the return of the product container and counting of remaining capsules at completion of the study.
Sponsors
Gencor Pacific Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Male and female participants aged 18 years and above Diagnosed with type 1 diabetes or type 2 diabetes Currently prescribed medications for diabetes, including metformin and/or insulin Have been medically diagnosed with peripheral neuropathy Experiencing neuropathic pain for > 3 months Score >4 on Neuropathic Pain Diagnostic Questionnaire (DN4) OR Score >12 on Self-reported Leeds Assessment of Neuropathic Symptoms and Signs (s-LANSS). Participants who can provide informed consent.
Exclusion criteria
Any clinically relevant abnormal findings which, in the opinion of the investigators/clinicians, may put participant at risk of adverse events. Potential for peripheral neuropathy due to the following causes will be excluded: hereditary sensory neuropathy, vitamin B12 or folate deficiency, paraneoplastic diseases, advanced liver disease, kidney disease, hypothyroidism, prolonged phenytoin or immunosuppressive drug use. Pregnant, planning to become pregnant or breastfeeding women. Those with alcohol or substance abuse health issues. Allergy or sensitivity to any of the ingredients in the investigational products.
Outcome results
None listed