Use of Cannabidiol for the Treatment of Inflammatory Bowel Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- reduction of 70 points in CDAI
研究概览
简要总结
There are many anecdotal reports about improvement of Inflammatory bowel diseases (IBD) with cannabis smoking. The most effective anti inflammatory compound known today is cannabidiol. cannabidiol can be extracted from the cannabis plant, it has no central effect and is fat soluble so it can be given as drops in oil. Doses of up to 500mg did not cause any side effects.
The aim of the proposed study is to examine in a double blind placebo controlled fashion the effect of cannabidiol on disease activity in patients with IBD.
详细描述
Background: Inflammatory bowel diseases (IBD) are relatively common disease with a rising incidence. Treatment includes various immunocompromising agents including corticosteroids, immunomodulators and biologic agents. Current treatment is not always effective and has many side effect.
Cannabinoids have been known to have anti inflammatory effect, probably via the CB2 receptor. There are many anecdotal reports of cannabinoids in inflammatory disease such as rheumatoid arthritis, and the impression is that cannabinoids do have an ameliorating effect on IBD and that side effects are negligible. However, there are no placebo controled trials in human subjects.
The cannabis plant contains about 600 ingredients, and it is not known which are the active ingredients affecting IBD. The most effective anti inflammatory compound known today is cannabidiol. Cannabidiol can be extracted from the cannabis plant, it has no central effect and is fat soluble so it can be given as drops in oil. Doses of up to 500mg did not cause any side effects.
The aim of the proposed study is to examine in a double blind placebo controlled fashion the effect of cannabidiol on disease activity in patients with IBD.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis IBD at least 3 months before recruitment will be eligible to the study.
- •Patients with active disease who are resistant to either 5 ASA, steroids or immunomodulators, or who can not receive those drugs due to adverse reactions will be offered the possibility of receiving cannabidiol at a dose of 10 mg in sub lingual drops or drops of olive oil as placebo.
- •Disease activity index of either CDAI of more then 200 in Crohn's disease or Mayo score above 3 in UC.
- •Age above 20.
排除标准
- •Patients with a known mental disorder
- •Patients who are deemed to be at a high risk of abuse or addiction to the study drug.
- •Pregnant women
- •Patients who are sensitive to any of the ingredients of the study medication.
- •Patients who are unable to give informed consent.
- •Patients who may need surgery in the near future.
研究组 & 干预措施
cannabidiol in drops
cannabidiol given in drops of olive oil sub lingual 5 mg twice daily
干预措施: cannabidiol (Drug)
placebo in drops
olive oil given in drops sub lingual
干预措施: placebo in drops (Drug)
结局指标
主要结局
reduction of 70 points in CDAI
时间窗: 8 weeks
次要结局
- change in quality of life during the study(8 weeks)
- any adverse events during study period(8 weeks)