This study consists of a randomized, double-blind, placebo-controlled crossover trial with open label extension evaluating a topical natural health cream containing ß-caryophyllene alone and in combination with 0.025% capsicum oleoresin against placebo. At the end of the randomized controlled phase of the trial all participants will be given open-label combination cream to be administered over the subsequent 3 weeks. Primary Endpoint: Evaluation of improvement in pain interference as measured by the BPI in individuals who are experiencing pain due to osteoarthritis of the knee. Secondary Endpoints: Secondary endpoints are: Confirmation of safety of the topical cream when used daily over 10 weeks. Further evaluation will include overall patient satisfaction with the products tested.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
56
BetaC + Capsacin Topical Cream applied to painful knee area 3 times per day.
BetaC Topical Cream Cream applied to painful knee area 3 times per day.
Placebo Cream applied to painful knee area 3 times per day.
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada
Pain Score Diary
Change in mean daily pain diary score from baseline (average pain score over 7 days pre-treatment) to post treatment
Time frame: 2 weeks
BPI-Short Form
Time frame: 12 weeks
Patient's Global Impression of Change
Time frame: 12 weeks
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