Pain
Conditions
Brief summary
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.
Interventions
OTHERBetaC + Capsaicin Topical Cream
BetaC + Capsacin Topical Cream applied to painful knee area 3 times per day.
OTHERBetaC Topical Cream
BetaC Topical Cream Cream applied to painful knee area 3 times per day.
Placebo Cream applied to painful knee area 3 times per day.
Sponsors
Panag Pharma Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score Diary | 2 weeks | Change in mean daily pain diary score from baseline (average pain score over 7 days pre-treatment) to post treatment |
Secondary
| Measure | Time frame |
|---|---|
| BPI-Short Form | 12 weeks |
| Patient's Global Impression of Change | 12 weeks |
Countries
Canada
Outcome results
None listed