在失眠的老年人中Kami Guibi-tang (KGT) 的效果:来自单一中心的研究方案,随机,双盲,安慰剂控制的试验
Kyeong-Hwa Lee1, Han-Gyul Lee2, Seungwon Kwon2
1Department of Clinical Korean Medicine, Graduate School, Kyung Hee University, Seoul, Republic of Korea.
BMC complementary medicine and therapies
|October 23, 2023
概括
这项研究方案评估Kami Guibi-tang (KGT) 对老年人的失眠. 它对KGT进行评估.
科学领域:
- 老年学是一门学科.
- 综合医学是一个整体的医学.
- 临床试验方法论 临床试验方法论
背景情况:
- 失眠的患病率随着年龄的增长而增加,影响了老年人的认知功能.
- 卡米吉比唐 (KGT) 是东亚用于治疗失眠,遗忘和抑郁症的传统草药处方.
- 积极管理老年人的失眠对于保持认知健康和生活质量至关重要.
研究的目的:
- 评估Kami Guibi-tang (KGT) 在患有失眠的老年人中的疗效和安全性.
- 研究KGT对老年人的睡眠质量,认知功能,生活质量和抑郁症的影响.
- 为了确定认知功能的改善与失眠症状的改善是否相关.
主要方法:
- 一个单中心,双盲,随机对照试验,涉及60名患有失眠和主观认知衰退的老年人.
- 参与者将被随机分配,接受KGT颗粒或安慰剂每天三次,持续12周.
- 评估包括睡眠 (PSQI-K,ISI-K),认知功能 (SNSB-D),生活质量 (SF-36),在基线,治疗结束和随访时的抑郁症 (S-GDS).
主要成果:
- 主要结局是12周和24周的KGT和安慰剂组之间匹兹堡睡眠质量指数-韩国语 (PSQI-K) 总得分的差异.
- 二次结果包括失眠严重程度指数-韩国语 (ISI-K),首尔神经心理查电池-Dement (SNSB-D),SF-36和老年抑郁量表 (S-GDS) 的简短版本的变化.
- 安全性将通过血液检测,心电图和整个研究期间的不良事件报告来监测.
结论:
- 本协议概述了一项严格的临床试验,以评估KGT在失眠的老年人中的疗效和安全性.
- 这项研究将提供有关KGT对老年人群睡眠和认知健康的潜在益处的宝贵数据.
- 这些发现将有助于基于证据的综合医学方法来管理老年人的失眠和相关的认知衰退.
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