Topical Use of 20% Beta Caryophyllene Alone And In Combination With 0.025% Capsaicin for Pain Caused by Osteoarthritis Of The Knee

Study Overview
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Brief Summary
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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.

Official Title
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Randomized, Double Blind, Placebo Controlled Crossover Trial With Open Label Extension Of Topical 20% Beta Caryophyllene Alone And In Combination With 0.025% Capsaicin In The Treatment Of Pain Caused By Osteoarthritis Of The Knee

Conditions
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Pain

Intervention / Treatment
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* Other: BetaC + Capsaicin Topical Cream
* Other: BetaC Topical Cream
* Other: Placebo Topical Cream


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Osteoarthritis of the knee according to American College of Rheumatology criteria: Knee pain with 3 of the following: age >50 years stiffness less than 30 min crepitus, bony tenderness, bony enlargement, no palpable warmth Moderate to severe pain, as defined by an average 7-day pain score of greater than 4.0 on an 11-point numerical rating scale for pain intensity (NRS-PI). All concurrent medications taken for any reason stable for 14 days Ability to follow protocol with reference to cognitive and situational factors (e.g. stable housing, ability to attend visits) Ability to read and write English Willing and able to give informed consent Exclusion Criteria: Currently using other topical agents for treatment of pain or inflammation Use of glucosamine, methysulfonylmethane or other regular anti-inflammatories within 2 weeks prior to completing baseline pain measure and during the trial Presence of significant medical disorder that would compromise the participant's safety to take part in the trial (e.g. cancer, immunosuppressed) Pregnant and breastfeeding women. Type I or Type II diabetes and other endocrine disorders Use of exercise or transcutaneous electrical nerve stimulation prior to and during the trial A history or present disease (i.e. inflammatory, infectious joint disease) which may affect the outcome of the trial Currently taking NHPs for joint health Currently enrolled in other clinical trial involving a pharmaceutical treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BetaC + Capsacian<br>1-3 mls BetaC + Capsacian applied to the painful areas, once upon awakening, once mid day and once before bed-time, each day for two (2) weeks. | Other: BetaC + Capsaicin Topical Cream<br>* BetaC + Capsacin Topical Cream applied to painful knee area 3 times per day.<br>|
| Active Comparator: BetaC Only<br>1-3 mls BetaC applied to the painful areas, once upon awakening, once mid day and once before bed-time, each day for two (2) weeks. | Other: BetaC Topical Cream<br>* BetaC Topical Cream Cream applied to painful knee area 3 times per day.<br>|
| Placebo Comparator: Placebo<br>1-3 mls Placebo applied to the painful areas, once upon awakening, once mid day and once before bed-time, each day for two (2) weeks. | Other: Placebo Topical Cream<br>* Placebo Cream applied to painful knee area 3 times per day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score Diary | Change in mean daily pain diary score from baseline (average pain score over 7 days pre-treatment) to post treatment | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BPI-Short Form |  | 12 weeks | 
| Patient's Global Impression of Change |  | 12 weeks |