NCT06513507进行中（未招募）不适用
A Clinical Study to Assess the Efficacy of Cannabigerol in Patients with Active Rheumatoid Arthritis.
Raphael Pharma2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2024年6月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change in inflammatory markers from Baseline to Week 8
研究概览
简要总结
This is a single-group exploratory longitudinal prospective study lasting 8 weeks. The study aims to measure the efficacy of purified cannabigerol (CBG) in patients with active rheumatoid arthritis using laboratory and self-reported outcome measures.
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
盲法说明
No blinding will be performed in this study. All participants and investigators will know the treatment being administered.
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, over 25 years of age
- •Positive anti-CCP blood test
- •Active RA-related inflammation with at least 2 swollen joints
- •University graduate
- •Generally healthy with no uncontrolled chronic disease
- •Able to read, understand, and sign informed consent
- •Resides in the USA
- •Willing to comply with study requirements and avoid other cannabis products during the study period
排除标准
- •Pre-existing chronic conditions preventing adherence
- •Severe allergic reactions requiring an Epi-pen
- •Use of opiates in the last 4 weeks or cannabis in the last 8 weeks
- •Pregnant or breastfeeding women
- •Recent invasive medical procedure or surgery
- •Active malignancy or ongoing oncology treatment
- •Use of cytochrome P450 or 3A4 inhibitors
- •History of substance abuse
结局指标
主要结局
Change in inflammatory markers from Baseline to Week 8
时间窗: Baseline, Week 2, Week 4, Week 6, and Week 8
Measurement of blood levels of ESR (Erythrocyte Sedimentation Rate), CRP (C-Reactive Protein), IL6 (Interleukin 6), and TNFa (Tumor Necrosis Factor-alpha) at Baseline, Week 2, Week 4, Week 6, and Week 8.
次要结局
- Change in self-reported symptoms and quality of life from Baseline to Week 8(Baseline, Week 4, and Week 8)
研究者
研究点 (2)
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