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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Pain Score Diary
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Pain Score Diary
时间窗: 2 weeks
Change in mean daily pain diary score from baseline (average pain score over 7 days pre-treatment) to post treatment
次要结局
- Patient's Global Impression of Change(12 weeks)
- BPI-Short Form(12 weeks)