Phase 2 Peripheral Neuropathy Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults between 40 and 70 years of age
• People who have been diagnosed with Type 2 Diabetes
• People who are mobile and living independently
• People who weigh at least 50 kg
• People who have had a physical examination completed within the last 6 months
• People who have had liver enzyme blood tests (ALT and AST) done within the last 6 months showing normal results
• People who have a liver condition called NAFLD, provided their liver enzyme levels (ALT and AST) are no more than twice the upper limit of the normal range
• People whose results on a pain questionnaire (called the DN4) indicate mild to moderate diabetic nerve pain
• People whose nerve conduction test confirms at least mild diabetic nerve damage
• People who have signed the study consent form
• People who are able to complete written questionnaires, including having adequate vision to do so

Who may not be able to join:

• People who are considered high-risk or severely unwell, such as those with serious heart or lung disease, fluid build-up in the abdomen, kidney failure, or limb loss due to diabetes
• People with uncontrolled or severe heart disease, such as unstable chest pain, uncontrolled heart failure, or a recent heart attack
• People with a history of irregular heart rhythms, a heart attack within the past 2 years, or a stroke
• People with severe or uncontrolled breathing conditions, such as uncontrolled asthma, severe COPD, or dependence on oxygen
• People with severe or uncontrolled liver disease, such as cirrhosis, active hepatitis, or certain other liver conditions
• People whose liver enzyme levels (ALT or AST) are more than twice the upper limit of normal, or whose bilirubin levels are above the normal range
• People with severe or uncontrolled kidney disease, including those on dialysis or with uncontrolled kidney conditions causing significant protein loss
• People who have had a cancer diagnosis within the past 5 years (some low-risk skin cancers may be exempt — confirm with trial site)
• People with a history of seizures
• People who are blind or whose vision is too poor to complete the required questionnaires
• People with a known allergy or previous reaction to any ingredient in the study treatment, including natural strawberry flavouring
• Women who are currently pregnant or breastfeeding
• Women who are able to become pregnant and are not using an accepted form of contraception (confirm with trial site for approved methods)
• People with current uncontrolled mental health conditions, such as active suicidal thoughts, a current manic episode, or psychosis
• People who have had a diagnosis of a major depressive episode with active suicidal thoughts or a suicide plan within the past 5 years
• People who have attempted suicide in the last 10 years
• People whose score on a standardised suicide assessment scale (C-SSRS) is 5 or above at the start of the study
• People whose score on a depression scale (HADS-D) is 15 or above at the start of the study
• People who have used cannabis products in the past 30 days
• People who currently use or have a history of illicit drug use, or misuse of prescription medications within the past 5 years
• People who drink heavily — defined as 8 or more drinks per week for women, or 15 or more drinks per week for men
• People who are currently taking medications known to interact with CBD or cannabinoids (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.