Diabetic Neuropathies
Conditions
Interventions
This is a randomized, controlled, double-blind, two-arm clinical study consisting of two phases. Phase 1 has a total of 5 non-diabetic participants who will use the ointment with Cannabis extract rich
Sponsors
Hospital Universitário Pedro Ernesto da Universidade do Estado do Rio de Janeiro
Policlínica Universitária Piquet Carneiro da Universidade do Estado do Rio de Janeiro
Eligibility
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: In phase one, non-diabetic individuals will be included; aged between 40 and 60 years; both sexes; without comorbidities; not using or consuming, during the evaluation period, any Cannabis-based product; in phase two, individuals aged between 50 and 75 years will be included; of both sexes; with a diagnosis of Diabetes with Peripheral Neuropathy previously defined by the endocrinology team, in accordance with the protocols and guidelines adopted by the multidisciplinary team of the outpatient clinic; who present moderate or severe pain intensity, defined as a score equal to or greater than 4 on the Visual Numeric Scale, and a score greater than or equal to 4 on the Questionnaire for the diagnosis of neuropathic pain; recent blood glucose and glycated hemoglobin tests; history of attendance at medical appointments at the outpatient clinic
Exclusion criteria
Exclusion criteria: In phase one, patients under 40 and over 60 years of age will be excluded; those who have not consumed cannabis-based products; in phase two, patients under 50 and over 75 years of age will be excluded; patients with untreated active lesions; patients in continuous use of opioids, anti-inflammatories and/or use of cannabis derivatives by any route and/or dependence; patients with decompensated organic comorbidities and/or high-risk psychiatric conditions; current pregnancy or lactation; patients unable to understand the study protocol due to cognitive dysfunction or untreated psychiatric illness; report of sensitivity to cannabinoids, addressed in the first interview/evaluation, on an individual basis, respecting the participant's desire for confidentiality
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy and safety of Cannabis extract ointment with Cannabidiol in reducing pain intensity in patients with diabetic peripheral polyneuropathy, compared to ointment without the active ingredient. The variables will be analyzed for pain efficacy through specific questionnaires | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes related to nociceptive pain, the main focus of the limitations of affected patients, will be assessed on issues related to sleep quality, frequent complaints of anxiety attacks and depression, in order to encompass the expectation of a positive impact on the quality of life of affected patients. The variables that will be analyzed to assess quality of life will be sleep quality with the Pittsburgh Sleep Quality Index questionnaire and quality of life measuring anxiety and depression with the Hospital Anxiety and Depression questionnaire | — |
Countries
Brazil
Contacts
Public ContactLidiane Da Cunha
Hospital Universitário Pedro Ernesto da Universidade do Estado do Rio de Janeiro
Outcome results
None listed