Efficacy of a Topical Pain Relief Spray Containing Herbal Oil Extracts (Bonipar) Among Individuals With Acute and Chronic Musculoskeletal Pain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Change in Pain as Measured by Subjective Pain Intensity Rating (SPIR)
研究概览
简要总结
This study is a non-inferiority study comparing efficacy and onset of action between the herbal extracts topical solution, Bonipar, and diclofenac sodium topical solution, diclofenac topical solution 1.5%.
详细描述
This study is a non-inferiority study comparing efficacy and onset of action between the herbal extracts topical solution, Bonipar, and diclofenac sodium topical solution, diclofenac topical solution 1.5% (approved by the FDA as a topical analgesic). Approximately 168 Duke patients will be recruited from Duke Pain Clinic, and selected Duke primary care practices. Individuals who report acute (less than 3 months duration) or chronic musculoskeletal pain of any intensity will be considered for enrollment into the study. After obtaining consent, eligible subjects will be will be randomized to receive Bonipar or diclofenac topical solution 1.5%.
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)
盲法说明
The bottles will be labelled by pharmacy either "Drug A" or Drug B" according to their designation with a label affixed to cover any drug manufacturing labeling. Only the dispensing pharmacy will not be blinded.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Bonipar
干预措施: Bonipar (Drug)
Diclofenac topical solution 1.5%
干预措施: Diclofenac sodium topical solution 1.5% (Drug)
结局指标
主要结局
Change in Pain as Measured by Subjective Pain Intensity Rating (SPIR)
时间窗: Baseline (approximately 24 hours before consent) to approximately 1 week post administration of study drug (or comparator)
The SPIR is a patient-reported graduated scale where 0 = no pain and 10 = the maximum pain imaginable.
次要结局
- Number of Participants Who Experienced Adverse Effects and/or Complications(Up to approximately 1 week)
研究者
Winston Parris, MD
Professor Emeritus
Duke University