NCT01969474撤回1 期
Phase 1 Study to Study the Efficacy and Safety of Cannabis in the Treatment of Tinnitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Tinnitus handicap inventory score
研究概览
简要总结
The hypothesis of the study is that the use of Cannabis will attenuate the tinnitus level as experienced by 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Tinnitus lasting more than 3 months
- •Tinnitus Handicap Inventory score over 58
- •Treated previously for tinnitus (2 modalities)
排除标准
- •Prior use of drugs
- •Current use of Cannabis
- •Neurologic or Psychiatric disease
- •Heart Failure
- •Ischemic Heart Disease
- •Immune Deficiency
- •Acoustic Neuroma
研究组 & 干预措施
Cannabis
Experimental
Treatment with a Cannabis capsule
干预措施: Cannabis (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Tinnitus handicap inventory score
时间窗: 2 months
Patients will be monitored during a month (treatment time) and a month later
次要结局
未报告次要终点
研究者
Oron Yahav
MD
Wolfson Medical Center
研究点 (1)
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