Comparative Study on the Cognitive Function and Brain Imaging of Modified Suanzaoren Decoction and Eszopiclone in the Treatment of Primary Insomnia Patients With Yin Deficiency and Hyperactivity of Fire Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- The improvement of insomnia before and after treatment was assessed using the Pittsburgh Sleep Quality Index
研究概览
简要总结
The purpose of this study is to observe the cognitive function and clinical efficacy of modified Suanzaoren decoction and eszopiclone in the treatment of chronic insomnia disorder patients, and to investigate the possible neural mechanisms using MRI techniques.
详细描述
The subjects were enrolled and divided into two treatment groups using the randomized numeric table method. Each group received either modified Suanzaoren decoction or eszopiclone treatment for a period of 4 weeks. General demographic data were collected, and changes in sleep, mood, cognitive function, and rs-fMRI before and after treatment were observed. Assessment tools included the Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), Hamilton Anxiety Scale (HAMA), and Hamilton Depression Scale (HAMD) for subjective measures, as well as the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and polysomnography (PSG) for objective evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have adequate comprehension ability, with at least 9 years of education.
- •Western medical diagnosis criteria (meeting the diagnostic criteria for chronic insomnia disorder in ICSD-3).
- •Patient's subjective dissatisfaction with either the total duration or quality of sleep: difficulty falling asleep, difficulty maintaining sleep, or early awakening.
- •Frequency of sleep problems: occurring at least 3 nights per week, and persisting for at least 3 months.
排除标准
- •Individuals who have used sedatives or hypnotics, or psychiatric medications in the week prior to enrollment.
- •Individuals who regularly consume strong tea, have a high smoking volume, or are dependent on coffee.
- •Women who are pregnant or breastfeeding.
- •Patients with severe primary diseases such as severe cardiovascular and cerebrovascular diseases, other mental disorders, or severe obstructive sleep apnea syndrome.
- •Individuals with allergies or multiple drug allergies.
研究组 & 干预措施
suanzaoren decoction
The modified Suanzaoren decoction consists of 30.0g of jujube kernel, 15.0g of Chuanchang rhizome and poria, 3.0g of licorice, and 3.0g of amber. It is administered once in the morning and once in the evening.
干预措施: suanzaoren decoction (Drug)
eszopiclone
Eszopiclone: Take 1mg nightly before bedtime.
干预措施: Eszopiclone 1 mg (Drug)
结局指标
主要结局
The improvement of insomnia before and after treatment was assessed using the Pittsburgh Sleep Quality Index
时间窗: 4 weeks
The Pittsburgh Sleep Quality Index (PSQI) is a self-reported questionnaire that assesses sleep quality and disturbances over a one-month time interval. It consists of 19 items that generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.
次要结局
- The anxiety condition before and after treatment is evaluated by Hamilton Anxiety Rating scale(4 weeks)
- The cognition function before and after treatment is evaluated by Repeatable Battery for the Assessment of Neuropsychological Status(4 weeks)
- The sleep condition before and after treatment is reflected using polysomnography(4 weeks)
- The depression condition before and after treatment is evaluated by Hamilton Depression Rating scale(4 weeks)
研究者
Guo Wenbin
Professor of Psychiatry Department of Psychiatry of the Second Xiangya Hospital, Central South University
Central South University