Use of Cannabidiol for the treatment of Diabetic Neuropathic Pain.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
A water-soluble sublingual tablet containing 20 mg of cannabidiol (CBD) and 0.1 mg of a proprietary blend of terpenes.
Dr. Nakadar's Office
Sterling Heights, Michigan, United States
Impact of Pure Green CBD tablets on diabetic neuropathy pain using a daily self-reported pain scale score.
To evaluate the safety and efficacy of Pure Green CBD sublingual tablets for the treatment of chronic diabetic neuropathic pain patients by evaluating their daily pain scale score reported as 0-10 where 0 is no pain and 10 is the worst pain possible as self-reported with every dose taken by the patient in the smart phone app. The objective is to reduce the patients average daily pain scale score to less than 5.
Time frame: Three Weeks
Impact of Pure Green CBD tablets on the quality of life of Diabetic Neuropathy Patients
To evaluate the impact of Pure Green CBD sublingual tablets on the quality of life of diabetic neuropathy patients measured by World Health Organization's quality of life questionnaire, . The objective is to examine quality of life metrics: overall quality of life and general health, physical health, psychological, social, and environment as measured on a 1-5 scale before and after the study.
Time frame: Three Weeks
Impact of Pure Green CBD tablets on sleep improvement of Diabetic Neuropathy Patients
The Pittsburgh Sleep Quality Index will be used to compare pre and post Pure Green CBD tablet study on sleep changes. Patients will be asked questions before beginning the study and after completion.
Time frame: Three weeks
Impact of Pure Green CBD tablets on anxiety of Diabetic Neuropathy Patients
The Hamilton Anxiety rating scale questionnaire will be administered before the study begins and after completion to examine the impact of Pure Green CBD tablets on anxiety in diabetic neuropathy pain patients. The scale of 0-4 will be used where 0 is no anxiety present and 4 is very severe anxiety.
Time frame: Three Weeks
Impact on the use of sublingual tablets as the route of administration
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To explore the impact of sublingual administration on patient compliance by evaluating the number of tablets taken per day as entered by the patients into the smart phone app.
Time frame: Three Weeks