Topical Use of 20% Beta Caryophyllene Alone And In Combination With 0.025% Capsaicin for Pain Caused by Osteoarthritis Of The Knee
- Conditions
- Pain
- Interventions
- Other: BetaC + Capsaicin Topical CreamOther: Placebo Topical CreamOther: BetaC Topical Cream
- Registration Number
- NCT03152578
- Lead Sponsor
- Panag Pharma Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description BetaC + Capsacian BetaC + Capsaicin Topical Cream 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. Placebo Placebo Topical Cream 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. BetaC Only BetaC Topical Cream 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Patient's Global Impression of Change 12 weeks BPI-Short Form 12 weeks
Trial Locations
- Locations (1)
QEII Health Sciences Centre
🇨🇦Halifax, Nova Scotia, Canada