Impact of Zao Ren An Shen (ZRAS) capsule on chronic insomnia patients' insomnia severity: A randomized-controlled trial

This study is a randomized-controlled-trial that aims to assess the efficacy and safety of Zao Ren An Shen (ZRAS) capsule, a Chinese herbal medicine product, for chronic insomnia. After a 1-week placebo run-in, the participants will be randomized to either the experimental group or the placebo group and asked to take three capsule of either ZRAS or placebo every day before bedtime for four weeks. The outcomes will be assessed continuously with a sleep diary and actigraphy, and at baseline, mid-treatement (week 2), post-treatment and follow-up (week 8) with questionnnaires about insomnia severity, fatigue severity, psychological status, and quality of life. The hypothesis is that ZRAS is efficient and safe for chronic insomnia.
The dataset relates to the clinical trial ACTRN12619000140156 Investigation of the efficacy and safety of Zao Ren An Shen (ZRAS) capsule for chronic insomnia.
This data cannot be shared publicly due to ethics approval conditions.
To discuss this data, please contact the NICM Health Research Institute [e-mail].

本研究为一项随机对照试验（randomized-controlled-trial），旨在评估中药制剂枣仁安神（Zao Ren An Shen, ZRAS）胶囊治疗慢性失眠的有效性与安全性。受试者完成为期1周的安慰剂导入期后，将被随机分配至试验组或安慰剂组，需于每日睡前服用3粒受试胶囊或安慰剂，持续4周。研究结局将通过睡眠日志与体动记录仪（actigraphy）持续监测，并在基线、治疗中期（第2周）、治疗结束时及随访阶段（第8周），采用失眠严重程度、疲劳严重程度、心理状态及生活质量相关问卷进行评估。本研究假设枣仁安神胶囊治疗慢性失眠安全有效。
本数据集关联临床试验ACTRN12619000140156《枣仁安神胶囊治疗慢性失眠的有效性与安全性研究》。
受伦理审批条款约束，本数据集无法公开共享。
如需洽谈本数据集的使用相关事宜，请联系NICM健康研究院（NICM Health Research Institute），联系邮箱：[e-mail]。