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功能性消化不良的草药Yukgunja-Tang:一个随机,受控,多中心临床试验的协议
Boram Lee1, Na-Yeon Ha2, Hyo-Ju Park3
1KM Science Research Division, Korea Institute of Oriental Medicine, Daejeon 34054, Republic of Korea.
Healthcare (Basel, Switzerland)
|May 27, 2023
概括
这项研究评估了Yukgunja-tang对功能性消化不良 (FD) 的评估. 它将其有效性,安全性和成本效益与Pyeongwi-san和临床试验中的常规护理进行比较.
科学领域:
- 整合和补充医学是整合和补充医学.
- 胃肠病学 胃肠病学
- 临床试验 临床试验
背景情况:
- 功能性消化不良 (FD) 是一种常见的胃肠道疾病.
- 优贡贾唐是一种传统的草药,经常用于东亚的FD.
- 与其他FD治疗方法比较Yukgunja-tang的证据有限.
研究的目的:
- 为了比较Yukgunja-tang与Pyeongwi-san的有效性,安全性和成本效益,以及用于治疗FD的通常护理.
- 评估这些治疗对消化不良症状,生活质量和相关生物标志物的影响.
- 为使用Yukgunja-tang在FD管理中提供强有力的临床证据.
主要方法:
- 一个随机的,评估者盲目的,受控的,多中心的,三臂临床试验,涉及140名被诊断为罗马IV型FD的参与者.
- 参与者被分配到Yukgunja-tang (n=56),Pyeongwi-san (n=56) 或通常护理 (n=28) 组,持续6周.
- 结局包括总腹症状尺度,二次症状尺度,生活质量,焦虑/抑郁和血清胆固醇水平,在多个时间点评估至24周.
主要成果:
- 主要结局: 总腹症状尺度. 主要结局: 全腹症状尺度.
- 二次结局:单个腹症状尺度,整体治疗效果,腹视觉模拟尺度,FD相关的生活质量,医院焦虑和抑郁量表,EuroQol-5维度,模式识别和血清乙/甲-氨酸水平.
- 通过监测不良事件和实验室测试进行安全评估.
结论:
- 这项研究旨在确定Yukgunja-tang是否是功能性消化不良的有效,安全和经济有效的治疗方法.
- 结果将为临床实践提供有关Yukgunja-tang用于FD的信息.
- 这项试验将为传统草药在胃肠病学中的比较疗效提供有价值的数据.
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