Combined THC and CBD Drops for Treatment of Crohn's Disease, a Phase II Double Blind Placebo Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Treatment sucsess will be defind as a decrease of at least 100 points in CDAI after 8 weeks of treatment.
研究概览
简要总结
There are many reports about efficacy of Cannabis in Crohn's disease but no controlled trials. The aim of the proposed trial is to investigate the efficacy of oil containing the cannabinoids THC and CBD given by mouth for induction of remission in Crohn's disease.
详细描述
The investigators have recently published a retrospective observational study about the beneficial effect of cannabis in Crohn's disease. The investigators have also concluded a double blind placebo controlled study of Inhaled cannabis in the treatment of Crohn's disease. Both studies have shown significant symptomatic improvement of disease. However, objective parameters of inflammation were not measured. The question arises as to whether the observed improvement is merely symptomatic or due to a real change in inflammation. In addition, administration per os is a healthier option than smoking but the efficacy of oral cannabis was not investigated.
The aim of the proposed study in to evaluate the efficacy of drops of cannabis oil in crohn's disease patients compared to placebo. Treatment success will be defined as a decrease of at least 100 points in CDAI after 8 weeks of treatment.
Secondary aims:
- Remission of disease i.e CDAI of less the 150 points.
- Improvement of at least one point in Endoscopic disease activity index
- Improvement of CRP and calprotectine
- Improvement of blood cytokine levels
- Improvement of at least 30 points in quality of life as measured by the SF 36. In addition the investigators will monitor side effects by questionnaires addressed to the patients and to a significant relative of the patients.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of Crohn's disease of at least 3 months duration, which was proved by either endoscopy or appropriate imaging study.
- •Patients who have failed treatment with either 5 ASA or corticosteroids or immunomodulators or biologic agents, or steroid dependant patients, or patients who were treated by the above mentioned drugs and could not tolerate them due to side effects.
- •Age 20 or older.
- •Able to sign informed concent
- •Active Crohn's disease with a CDAI 200 or more.
排除标准
- •Patients with a diagnosis of a mental disorder
- •Patients who by the judgment of their physician are likely to develop drug addiction.
- •Pregnant women or women who are intending to become pregnant
- •Patients with a known cannabis allergy
- •Patients who are not capable of giving an informed consent
- •Patients with an impending operation due to Crohn's disease.
研究组 & 干预措施
THC 5 mg/ml and CBD 50 mg/ml.
olive oil containing THC 5 mg/ml and CBD 50 mg/ml. which will be taken twice daily.
干预措施: THC 5mg/ml and CBS 50mg/ml (Drug)
Placebo
olive oil but without any active ingredients.
干预措施: Placebo (Drug)
结局指标
主要结局
Treatment sucsess will be defind as a decrease of at least 100 points in CDAI after 8 weeks of treatment.
时间窗: 8 weeks
The aim of the proposed study in to evaluate the efficacy of drops of cannabis oil in crohn's diseas patients compared to placebo. Treatment sucsess will be defind as a decrease of at least 100 points in CDAI after 8 weeks of treatment.
次要结局
- endoscopic improvment(8 week)
- Improvment of CRP and calprotectine(8 week)
- Remission of disease(8 weeks)
- Improvment of blood cytokine levls(8 weeks)
- Improvment of at least 30 points in quality of life as measured by the SF 36.(8 weeks)