Randomized, Double Blind, Placebo Controlled Trial With Open Label Extension Of Delivra Joint Health Cream In The Treatment Of Pain Caused By Osteoarthritis Of The Knee
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 4
- 主要终点
- Change in mean daily pain diary score from baseline
研究概览
简要总结
The current clinical trial is designed to test the analgesic and anti-inflammatory efficacy of a topical cream compared to a placebo cream. The study population will be those with mild to moderate osteoarthritis of the knee.
The trial will also provide information about potential side effects and verify the safety of this composition. Blood levels will be done to assess inflammation and to determine whether any systemic absorption has occurred.
Hypothesis/Purpose
- Pain scores after active treatment will be significantly reduced in comparison to placebo.
- There will be an improvement in stiffness and physical function as measured by the WOMAC using the active cream as compared to placebo.
- There will be a decrease in the level of inflammation assessed at baseline, end of week 3 and end of week 6.
- The blood concentration of the active ingredient in the topical cream will not exceed the maximum daily dose that will be consumed by participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 100 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:
- •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 (eg. stable housing, ability to attend visits)
- •Ability to read and write English
- •Willing and able to give informed consent
排除标准
- •Currently taking opioids, NSAIDs, warfarin, other anticoagulants, other topical agents for treatment of pain or inflammation
- •Allergy to tea tree oil, latex, avocado, soy
- •Active conditions such as exzema or psoriasis
- •Presence of significant medical disorder that would compromise the participant's safety to take part in the trial (eg. cancer, immunosuppressed)
- •Individuals with a history or current disease which may affect the outcome of the trial (ie. Inflammatory, infections joint disease).
- •Allergy to plants of the Asteraceae/Compositae/Daisy family.
- •Pregnant and breastfeeding women.
- •Allergy or other contraindication for acetaminophen use.
- •Exercise or transcutaneous electrical nerve stimulation should be excluded prior to and during the trial.
研究组 & 干预措施
Placebo
1-1.5 ml applied to the skin over the knee in the morning and at bedtime over the entire study period, for a total of 2-3 ml/day.
干预措施: Topical Arthritis Cream (Other)
Topical Arthritis Cream
1-1.5 ml applied to the skin over the knee in the morning and at bedtime over the entire study period, for a total of 2-3 ml/day.
干预措施: Topical Arthritis Cream (Other)
结局指标
主要结局
Change in mean daily pain diary score from baseline
时间窗: three weeks
The primary outcome measure will consist of change in mean daily pain diary score from baseline (average pain score over 7 days pre-treatment) to the final 3 days of the third treatment week. Therefore, the primary analysis is a between group comparison (placebo versus test product) over 3 weeks.
次要结局
- PGSS(six weeks)
- WOMAC(Six weeks)
- PGIC(six weeks)
- BPI-SF(six weeks)