Actively Recruiting
Randomized Placebo Controlled Trial Assessing Levagen+ for Symptoms of Diabetic Peripheral Neuropathy
Led by RDC Clinical Pty Ltd · Updated on 2025-07-23
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
R
RDC Clinical Pty Ltd
Lead Sponsor
G
Gencor Pacific Limited, Hong Kong
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of Levagen+ supplementation on symptoms of diabetic peripheral neuropathy (DPN) in adults aged 18 to 75 years with this condition. This Phase 2 clinical trial aims to determine how Levagen+ impacts neuropathic pain and other related health measures over a 12-week period. The study compares Levagen+ to a placebo to assess its potential benefits for people with DPN. Participants will be randomly assigned to take either Levagen+ capsules or placebo capsules twice daily with water after food. Each Levagen+ capsule contains 150 mg of palmitoylethanolamide (PEA), totaling 300 mg daily. The placebo capsules contain microcrystalline cellulose. The treatment period lasts 12 weeks, during which participants attend remote visits every 3 weeks and visit a local pathology center for blood draws. During the study, participants will be monitored for changes in neuropathic pain severity, symptom inventories, safety through adverse event reporting and lab markers, vital signs, sleep quality, mood, glycemic control, body measurements, and rescue medication use. Assessments occur from baseline through week 12. The trial includes detailed safety and efficacy measurements to understand the effects of Levagen+ on diabetic peripheral neuropathy symptoms.
CONDITIONS
Brief Title
Levagen+ Efficacy Study on Diabetic Peripheral Neuropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Using prescribed glucose-lowering medications at a stable dose for 3 months or more
- Diagnosed with type 1 or type 2 diabetes
- Scoring 12 or more on the Self-reported Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS)
- Able to provide informed consent
- Agree not to change diet or exercise habits during the study
- Agree not to participate in another clinical trial during the study
- Able to attend a local pathology collection centre
You will not qualify if you...
- Peripheral neuropathy caused by conditions other than diabetes
- Serious illnesses such as advanced liver or kidney disease, mood disorders, neurological disorders, heart conditions, or peripheral vascular disease
- Unstable illnesses including uncontrolled diabetes or thyroid dysfunction
- Current cancer or recent cancer treatment within 2 years
- Taking anticoagulation therapy or blood thinners like warfarin or heparin
- Using herbal pain relief medicines like medicinal cannabis or turmeric
- Active smokers, nicotine users, or drug abusers
- Chronic alcohol use exceeding 14 drinks per week
- Females who are pregnant, lactating, or trying to conceive
- Allergic or intolerant to ingredients in study capsules
- Difficulty swallowing capsules
- Participation in another clinical trial within the past month
- Any condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants take Levagen+ or placebo capsules twice daily with water after food to assess effects on diabetic peripheral neuropathy symptoms.
Visits at baseline and periodic assessments during treatment
Trial Site Locations
Total: 1 location
1
RDC Clinical
Fortitude Valley, Queensland, Australia, 4006
Actively Recruiting
Research Team
A
Amanda Rao
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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