Effect of Valerian Root on Sleep in Rheumatoid Arthritis

缬草根对类风湿性关节炎睡眠的影响

• 批准号: 6884948
• 负责人: DIANA TAIBI BUCHANAN
• 金额: $ 1.74万
• 依托单位: UNIVERSITY OF VIRGINIA
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-02-02 至 2005-08-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6884948
• 关键词: alternative medicine; angiosperms; chemotherapy; clinical research; drug screening /evaluation; human subject; human therapy evaluation; medicinal plants; patient oriented research; plant extracts; predoctoral investigator; rheumatoid arthritis; sleep; sleep disorders

DESCRIPTION (provided by applicant): Sleep disturbances are prevalent among persons with rheumatoid arthritis (RA), and are not adequately relieved by conventional health care. The herb valerian has been demonstrated to improve objective and subjective measures of sleep, but has not been tested in persons with RA. The proposed study is a placebo controlled, randomized clinical trial investigating whether use of valerian extract (600 mg) one hour before bedtime for five nights will improve objective sleep outcomes (improved sleep efficiency, reduced awakenings, reduced sleep latency) and subjective sleep outcomes (reduced subjective sleep latency, improved sleep quality) compared to a placebo in persons with RA. Forty participants will be randomized to receive valerian or a placebo (20 per group). Participants will wear a wrist actigraph (a watch-like device that provides sleep measures by detecting movement) and complete daily logs for seven days. The first two days will be baseline measurement (no treatment). The following five days participants will take the valerian or placebo one hour before bedtime. Between-groups and within-subjects differences will be analyzed using mixed effects ANCOVA models. The study is supported in part by the University of Virginia GCRC.

描述（由申请人提供）：睡眠障碍在类风湿性关节炎 (RA) 患者中普遍存在，并且传统的医疗保健无法充分缓解睡眠障碍。缬草已被证明可以改善客观和主观的睡眠指标，但尚未在类风湿性关节炎患者中进行测试。拟议的研究是一项安慰剂对照、随机临床试验，调查睡前一小时使用缬草提取物（600 毫克）连续五个晚上是否会改善客观睡眠结果（提高睡眠效率、减少觉醒、减少睡眠潜伏期）和主观睡眠结果（与安慰剂相比，RA 患者的主观睡眠潜伏期减少，睡眠质量提高）。四十名参与者将被随机分配接受缬草或安慰剂（每组 20 名）。参与者将佩戴腕部活动记录仪（一种类似手表的设备，通过检测运动来提供睡眠测量数据）并完成 7 天的每日日志。前两天将是基线测量（不进行治疗）。接下来的五天，参与者将在睡前一小时服用缬草或安慰剂。将使用混合效应 ANCOVA 模型分析组间和受试者内差异。该研究得到了弗吉尼亚大学 GCRC 的部分支持。