舒颗粒治疗失眠:双盲,随机,安慰剂对照试验的研究方案
Yu Gao1, Xiangbin Chen1, Yuxi Li1
1The Second Clinical Medical College of Guangzhou University of Chinese Medicine, Guangzhou, China.
Frontiers in pharmacology
|March 11, 2025
概括
这项研究调查了Shuhe颗粒 (SHG) 治疗失眠的有效性,解决了传统疗法的局限性. 随机对照试验旨在提供基于证据的SHG数据.
科学领域:
- 综合医学是一个整体的医学.
- 临床药理学 临床药理学
- 睡眠医学 睡眠医学
背景情况:
- 传统的失眠治疗面临诸多挑战,包括成,耐药性和复发.
- 舒颗粒 (SHG) 是一种中医药配方,用于治疗失眠,但缺乏可靠的临床试验证据.
- 需要高质量的证据来支持SHG在失眠管理中的使用.
研究的目的:
- 评估Shuhe颗粒 (SHG) 在治疗失眠方面的疗效和安全性.
- 提供基于证据的关于SHG在失眠治疗中的临床功效的数据.
- 在随机对照试验环境中,将SHG与安慰剂进行比较.
主要方法:
- 一个单中心,双盲,随机,平行组,安慰剂受控试验.
- 160名18-65岁的符合条件的患者将随机分配,接受SHG或安慰剂.
- 结果将在2个月内进行评估,主要关注失眠严重程度指数和包括睡眠质量,疲劳和情绪在内的次要措施.
主要成果:
- 该部分将在研究完成后填写.
- 预期的结果将详细介绍SHG对失眠的疗效和安全性.
- 将分析数据以确定SHG对初级和二级结果措施的影响.
结论:
- 这项研究预计将产生关于SHG对失眠的疗效和安全性的高质量证据.
- 这些发现将为临床实践提供有关SHG在失眠治疗中的使用的信息.
- 结果将为中国传统医学在治疗睡眠障碍方面的证据基础做出贡献.
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