KAVA KAVA in Generalized Anxiety: A Double-Blind Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 16
- 主要终点
- Hamilton Anxiety Scale
研究概览
简要总结
The purpose of this study is to evaluate the safety and effectiveness of the herbal medicine kava kava for the treatment of generalized anxiety disorder (GAD).
详细描述
Kava kava (KAV) is a plant-derived treatment widely used in Europe to treat anxiety disorders. Several studies suggest that KAV may be effective in reducing anxiety symptoms; however, trial data are limited. This study will compare KAV, the drug venlafaxine-XR (VEN), and placebo for the treatment of GAD.
This study will last 10 weeks. Participants will be randomly assigned to receive KAV, VEN, or placebo for 8 weeks. Participants will then undergo a 1-week tapering of their medication followed by an additional week of observation. Self-report scales and questionnaires will be used to assess the anxiety, depression, and functional impairment of participants. Side effects, vital signs, and laboratory measures will be monitored throughout the study.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of generalized anxiety disorder (GAD)
排除标准
- 未提供
研究组 & 干预措施
Herbal treatment kava
Kava
干预措施: Kava (Drug)
active antidepressant drug comparator
Venlafaxine ER
干预措施: Venlafaxine ER (Drug)
active antidepressant drug comparator
Venlafaxine ER
干预措施: Sugar pill (Drug)
Sugar pill
Inert placebo pills as duble dummy - up to 4 per day for kava and 3 per day for venlafaxine
干预措施: Sugar pill (Drug)
Herbal treatment kava
Kava
干预措施: Sugar pill (Drug)
结局指标
主要结局
Hamilton Anxiety Scale
时间窗: 8 weeks
次要结局
未报告次要终点