The Second Xiangya Hospital of Central South University
Changsha, China
NCT Number: NCT06452953
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Changsha, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The Suanzaoren decoction is a Chinese herbal formula known for nourishing the blood, calming the mind, and nourishing the heart and liver
Other names: Suan Zao Ren Tang
Eszopiclone is used in the treatment of various types of insomnia.
Other names: Estorra
Time frame: 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.
Time frame: 4 weeks
Polysomnography is a comprehensive test used to diagnose sleep disorders. It records various body functions during sleep, including brain waves, eye movements, muscle activity, heart rhythm, and breathing patterns. This information helps clinicians evaluate sleep quality and diagnose sleep disorders such as sleep apnea, insomnia, and REM behavior disorder.
Time frame: 4 weeks
The Hamilton Depression Rating Scale is a widely used tool to measure the severity of depression in individuals. It consists of 17 items that assess various symptoms of depression, such as mood, guilt, suicidal thoughts, and sleep disturbances. Each item is scored based on the severity of the symptom, and the total score indicates the overall severity of depression, with higher scores indicating more severe depression.
Time frame: 4 weeks
The Hamilton Anxiety Rating Scale (HAM-A) is a widely used tool for assessing the severity of anxiety symptoms in individuals. It consists of 14 items that measure various aspects of anxiety, including psychological, physical, and behavioral symptoms.
Time frame: 4 weeks
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) is a widely used neuropsychological assessment tool designed to evaluate cognitive function across various domains. It consists of 12 subtests that assess attention, language, visuospatial/constructional abilities, and immediate and delayed memory.
Central South University
Other
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
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