NCT04193631已完成1 期
A Controlled-Dose Study Using A One Time Low Dose Cannabidiol Tablet For The Treatment of Mild to Moderate Musculoskeletal Pain
Pure Green1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2019年12月7日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Impact of Pure Cannabidiol (CBD) tablets on safety in patient's with musculoskeletal pain using a self-reported pain scale score.
研究概览
简要总结
The purpose of the study is to evaluate whether Pure Green tablets is a better pain reliever for the treatment of mild to moderate musculoskeletal pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female at least 21 years of age;
- •Subject has mild to moderate musculoskeletal pain;
- •Pain for greater than or equal to 10 days of each month for 3 months prior to study entry for which the pain requires treatment.
- •Has an Numeric Pain Rating Scale (NPRS) score of 3 or greater,
- •If female, subject is practicing an approved method of birth control throughout the study;
- •Subject is willing and able to comply with all protocol-specified requirements;
- •Subject is willing to take Pure Green tablets only and will not take any other pain medications,
- •Subject is willing to provide his/her written informed consent to participate in the study as stated in the informed consent document.
- •Subject is willing to document pain scale scores in a diary.
排除标准
- •Subject has any condition for which the investigator does not feel the participant should be enrolled due to possible safety or compliance issues;
- •Subject has received treatment with an investigational drug or therapy within 30 days or 5 half-lives (whichever is longer) prior to Day
- •Subject has a known allergy to active or inert ingredients of Pure Green tablets;
- •Subject is taking a concomitant medication or treatment that would complicate use or interpretation of the study drug's effects (examples include: Cannabis (marijuana) or any cannabinoid products including Cannabidiol (CBD) or Tetrahydrocannabinol (THC); Any drug or herbal product that influences the endocannabinoid system (ECS));
- •Have serious cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other medical or psychiatric condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study.
- •Have a history of recurrent seizures other than febrile seizures.
- •Have current or pending disability compensation or litigation issues that may compromise response to treatment, in the opinion of the investigator.
- •Have a diagnosis of inflammatory arthritis (that is, rheumatoid arthritis) or an autoimmune disorder (excluding inactive Hashimoto's thyroiditis).
- •Use of acupuncture, chiropractic maneuvers, transcutaneous electrical nerve stimulation (TENS), or similar procedures aimed to relieve any kind of pain.
- •Patients who are anticipated by the investigator to require use of analgesic agents including but not limited to non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen/paracetamol, and opioids, or other excluded medication for the duration of the study.
- •Are unwilling or unable to comply with the data collection method used to record their patient rated outcome data.
研究组 & 干预措施
Pure Green Tablet
Experimental
A water-soluble sublingual tablet that contains 5 mg of cannabidiol (CBD).
干预措施: Cannabidiol (CBD) (Drug)
结局指标
主要结局
Impact of Pure Cannabidiol (CBD) tablets on safety in patient's with musculoskeletal pain using a self-reported pain scale score.
时间窗: 1 Day
To evaluate the safety and efficacy of Pure Green Cannabidiol (CBD) sublingual tablets for the treatment of musculoskeletal pain by having patients evaluate their Numeric Pain Rating Scale (NPRS) score reported as 0-10 where 0 is no pain and 10 is the worst pain possible.
次要结局
- To evaluate efficacy of a low dose of Cannabidiol (CBD) in the treatment of mild to moderate musculoskeletal pain.(1 Day)
研究者
研究点 (1)
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