Gao Yu, Chen Xiangbin, Li Yuxi, Shen Yuchuan, Chen Xinyi, Xu Qing, Peng Mengling, Xu Wen, Yuan Jiamin, Hu Yuanyuan, Chen Xiankun, Xu Biyun, Yang Zhimin
The Second Clinical Medical College of Guangzhou University of Chinese Medicine, Guangzhou, China.
The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China.
Front Pharmacol. 2025 Feb 24;16:1542897. doi: 10.3389/fphar.2025.1542897. eCollection 2025.
Modern medical treatment of insomnia is often associated with issues like addiction, drug resistance, and a high risk of relapse post drug withdrawal. To tackle these challenges, the Chinese medicine formula Shuhe granule (SHG) has been employed in insomnia treatment at Guangdong Provincial Hospital of Chinese Medicine. Despite this, there is currently a lack of reliable evidence from evidence-based trials to support the widespread use of SHG in insomnia treatment. Therefore, we have developed a randomized controlled trial to assess the efficacy and safety of SHG in insomnia treatment.
This study will be a single-center, double-blind, randomized, parallel group, placebo-controlled clinical trial involving a total of 160 eligible patients aged between 18 and 65. Participants will be randomly assigned to either the intervention group, receiving SHG, or the placebo group receiving placebo granules. Follow-up visits will occur every 2 weeks from baseline to 2 months. The primary outcome is the perceived insomnia severity measured by the Insomnia Severity Index. The secondary outcome measures include the Pittsburgh Sleep Quality Index, Fatigue Severity Scale, Patient Health Questionnaire, Generalized Anxiety Disorder, Visual Fatigue Analogue Scale, Traditional Chinese medicine syndrome score, and Polysomnography.
The results of the study are expected to provide evidence of high methodological and reporting quality on the efficacy and safety of SHG for insomnia.
http://itmctr.ccebtcm.org.cn/, ITMCTR2024000035.
现代医学治疗失眠常常伴随着成瘾、耐药以及停药后高复发风险等问题。为应对这些挑战，广东省中医院在失眠治疗中采用了中药配方舒和颗粒（SHG）。尽管如此，目前缺乏基于循证试验的可靠证据来支持舒和颗粒在失眠治疗中的广泛应用。因此，我们开展了一项随机对照试验，以评估舒和颗粒治疗失眠的疗效和安全性。
本研究将是一项单中心、双盲、随机、平行组、安慰剂对照的临床试验，共纳入160名年龄在18至65岁之间的合格患者。参与者将被随机分配到干预组，接受舒和颗粒治疗，或安慰剂组，接受安慰剂颗粒。从基线到2个月，每2周进行一次随访。主要结局是通过失眠严重程度指数测量的感知失眠严重程度。次要结局指标包括匹兹堡睡眠质量指数、疲劳严重程度量表、患者健康问卷、广泛性焦虑障碍、视觉疲劳模拟量表、中医证候评分和多导睡眠图。
本研究结果有望为舒和颗粒治疗失眠的疗效和安全性提供方法学和报告质量均较高的证据。
