This study is a prospective Phase 2, drug controlled, open-label study to evaluate the safety and efficacy of Pure Green sublingual tablets for the treatment of pain associated with osteoarthritis of the knee.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
10 mg CBD, 10 mg of THC, and a proprietary blend of terpenes.
Pure Green, LLC
West Bloomfield, Michigan, United States
RECRUITINGImpact of Pure Green sublingual tablets on pain due to osteoarthritis of the knee using a daily self-reported pain scale score.
To evaluate the safety and efficacy of Pure Green sublingual tablets for the treatment of pain due to osteoarthritis of the knee by having patients evaluate 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 4.
Time frame: 30 days
Impact of Pure Green sublingual tablets on general health and well-being of Osteoarthritis of the knee patients.
To evaluate the impact of Pure Green sublingual tablets on the general health and well-being of osteoarthritis of the knee patiens. The objective is to examine quality of life metrics: overall quality of life and general health, physical health, and knee pain as measured on a 1-5 scale before and after the study
Time frame: 30 Days
Impact of Pure Green sublingual tablets on sleep improvement of patients with osteoarthritis of the knee.
The Pittsburgh Sleep Quality Index will be used to compare pre and post Pure Green sublingual tablet study on sleep changes. Patients will be asked questions before beginning of the study and after completion.
Time frame: 30 Days
Impact of Pure Green sublingual tablets on anxiety of patients with osteoarthritis if the knee
The Hamilton Anxiety rating scale questionnaire will be administered before the study begins and after completion to examine the impact of Pure Green sublingual tablets on anxiety in patients with osteoarthritis of the knee. The scale of 0-4 will be used where 0 is no anxiety present and 4 is very severe anxiety.
Time frame: 30 Days
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: 30 Days