NCT04091789Unknown2 期
A Controlled-Dose Study Using Cannabinoid Combinations in a Rapidly Dissolvable Sublingual Tablet for the Treatment of Dysmenorrhea and Associated Pain Symptoms
Pure Green1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Impact of Pure Green tablet on menstrual pain as measured by a pain scale score
研究概览
简要总结
Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject is female and at least 21 years of age;
- •Subject has a regular, predictable menstrual cycle ranging in length from 21-35 days;
- •Subject has a diagnosis of primary dysmenorrhea with an average pain scale score of 5 or greater;
- •Subject is willing to provide her informed consent via DocuSign to participate in the study as stated in the informed consent document.
- •Subject knows how to use and is willing to use a smart phone app to record information.
排除标准
- •Subject is pregnant or lactating;
- •Subject has an allergy to cannabis (marijuana), the Cannabaceae plant family (e.g., hemp, hops), PEA, terpenes, citrus, or lavender, peppermint;
- •Subject has a known allergy to active or inert ingredients of Pure Femme tablets;
- •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 including CBD and THC; Any drug or herbal product that influences the endocannabinoid system (ECS));
- •Subject has a history of endometriosis, pelvic inflammatory disease, adenomyosis, leiomyomata, or chronic pelvic pain;
- •Subject has a history of migraines, tension headaches, or cluster headaches not associated with menstruation or is currently taking medication for headache treatment or prevention (e.g., tricyclic antidepressants, beta-blockers, anticonvulsants, triptans);
- •Subject is currently using any of the following medications or classes of medication routinely: opioids, anti-emetics, acetaminophen, NSAIDS, ergotamines, triptans, or, glucocorticoids;
- •Subject has shortness of breath associated with allergies;
- •Subject has uncontrolled asthma;
- •Subject has a fever and/or productive cough.
研究组 & 干预措施
Test Article
Experimental
Subjects will take Pure Femme sublingual tablets as directed, one tablet 2 days before, one tablet 1 day before, and then up to 3 tablets per day for 3 days (72 hours) during menstruation.
干预措施: Pure Femme Tablets (Drug)
结局指标
主要结局
Impact of Pure Green tablet on menstrual pain as measured by a pain scale score
时间窗: Two Months
The study objective is to examine the impact on Pure Green tablet on menstrual related pain. Patients will self report their pain scale score using 0-10 scale where 0 is no pain and 10 is the worst pain ever.
次要结局
- The impact of Pure Green tablets will be compared to patient's usual treatment of mentrual pain.(Two Months)
- Evaluate the impact of Pure Green tablets on menstrual related headache or migraine as evaluated by a questionnaire(Two Months)
- Impact of Pure Green tablets on mood disturbance as measured by the Steiner PMTS questionnaire.(Two Months)
- The impact of Pure Green tablets will be measured by the WHO QOL questionnaire comparing pre and post dosing responses.(Two Months)
研究者
研究点 (1)
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