NCT04088929已完成2 期
A Dose Controlled Diabetic Neuropathic Pain Study Using Non-Intoxicating Cannabidiol in a Rapidly Dissolvable Sublingual Tablet
Pure Green1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2019年9月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Impact of Pure Green CBD tablets on diabetic neuropathy pain using a daily self-reported pain scale score.
研究概览
简要总结
Use of Cannabidiol for the treatment of Diabetic Neuropathic 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
- •Subject is at least 21 years of age;
- •Subject has a diagnosis of chronic diabetic neuropathic pain condition as determined by the subject's health care or allied health provider for which medications other than cannabis, cannabinoids, or cannabis-based medicines are currently utilized;
- •Subject has a 7-day average pain scale score (recorded during the screening period) of ≥ 5;
- •If female, subject is postmenopausal (> 1 year), surgically sterile, or practicing an approved method of birth control throughout the study and for 5 months (150 days) after the last dose of study drug;
- •If female and of childbearing potential, subject has a denied pregnancy and has no desire to become pregnant throughout the duration of the study;
- •Subject is willing and able to provide his/her written informed consent to participate in the study as stated in the informed consent document;
- •Subject has access to a smart phone and knows how to use smart phone applications.
排除标准
- •Subject is pregnant or lactating;
- •Subject has an allergy to cannabis, the Cannabaceae plant family (e.g., hemp, hops, hackberry), PEA, terpenes, peppermint;
- •Subject has a known allergy to active or inert ingredients of Pure Green tablets;
- •Subject is currently treating their pain with cannabis, cannabinoids, cannabis-base medicine;
- •Subject is taking a concomitant medication or treatment that would complicate use or interpretation of the study drug's effects (examples include: Cannabis or any cannabinoid products; Any drug or herbal product that influences the endocannabinoid system (ECS));
- •Subject is taking marijuana (cannabis) in any form, chemicals or extracts or foods or beverages or topical creams, lotions, gels, patches containing marijuana (cannabinoids, or and cannabis derivatives) including synthetic marijuana and/or CBD for at least 30 days prior to this study., and does not promise to not take marijuana (cannabis) in any form, chemicals or extracts or foods or beverages or topical creams, lotions, gels, patches containing marijuana (cannabinoids, or and cannabis derivatives) including synthetic marijuana and/or CBD while participating in this study;
- •Subject is currently being treated with antibiotics for sinus, throat, or lung infections;
- •Subject has shortness of breath associated with allergies;
- •Subject has uncontrolled asthma;
- •Subject has a fever and/or productive cough;
- •Subject does not have access to a smart phone or does not know how to use a smart phone application.
研究组 & 干预措施
CBD for Treatment of Diabetic Neuropathic Pain
Experimental
Patients are instructed to take 3 total tablets a day, under the tongue, six hours apart for three weeks. Patients are to enter their pain scale score into the smartphone app as instructed during the initial site visit. Patients are to enter into the notes section of the app any additional information such as side effects (positive or negative), medication changes.
干预措施: CBD (Drug)
结局指标
主要结局
Impact of Pure Green CBD tablets on diabetic neuropathy pain using a daily self-reported pain scale score.
时间窗: Three Weeks
To evaluate the safety and efficacy of Pure Green CBD sublingual tablets for the treatment of chronic diabetic neuropathic pain patients by evaluating their daily pain scale score reported as 0-10 where 0 is no pain and 10 is the worst pain possible as self-reported with every dose taken by the patient in the smart phone app. The objective is to reduce the patients average daily pain scale score to less than 5.
次要结局
- Impact of Pure Green CBD tablets on anxiety of Diabetic Neuropathy Patients(Three Weeks)
- Impact of Pure Green CBD tablets on the quality of life of Diabetic Neuropathy Patients(Three Weeks)
- Impact of Pure Green CBD tablets on sleep improvement of Diabetic Neuropathy Patients(Three weeks)
- Impact on the use of sublingual tablets as the route of administration(Three Weeks)
研究者
研究点 (1)
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