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| Name | Class |
|---|---|
| The Third Hospital of Inner Mongolia Autonomous Region | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| suanzaoren decoction | Experimental | 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. |
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| eszopiclone | Active Comparator | Eszopiclone: Take 1mg nightly before bedtime. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| suanzaoren decoction | Drug | The Suanzaoren decoction is a Chinese herbal formula known for nourishing the blood, calming the mind, and nourishing the heart and liver |
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| Measure | Description | Time Frame |
|---|---|---|
| The improvement of insomnia before and after treatment was assessed using the Pittsburgh Sleep Quality Index | 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. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The sleep condition before and after treatment is reflected using polysomnography | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wenbin Guo | Central South University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Xiangya Hospital of Central South University | Changsha | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42157543 | Derived | Guo Z, Zhang L, Han Y, Yan H, Yao P, Lv D, Yuan Y, Zhao J, Chen L, Guo W. Altered Effective Connectivity of Precuneus Subregions and Associated Gene Profiles in Chronic Insomnia Disorder Patients Before and After Treatment. Brain Behav. 2026 May;16(5):e71448. doi: 10.1002/brb3.71448. | |
| 40778328 | Derived | Yao P, Guo X, Guo Z, Lin W, Liu M, Chen M, Li J, Cui LB, Lv D. Clinical efficacy of modified suanzaoren decoction compared to esazolam tablets in the treatment of chronic insomnia disorder. Front Psychiatry. 2025 Jul 24;16:1533652. doi: 10.3389/fpsyt.2025.1533652. eCollection 2025. |
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| ID | Term |
|---|---|
| D000069582 | Eszopiclone |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011719 | Pyrazines |
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| Eszopiclone 1 mg | Drug | Eszopiclone is used in the treatment of various types of insomnia. |
|
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| 4 weeks |
| The depression condition before and after treatment is evaluated by Hamilton Depression Rating scale | 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. | 4 weeks |
| The anxiety condition before and after treatment is evaluated by Hamilton Anxiety Rating scale | 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. | 4 weeks |
| The cognition function before and after treatment is evaluated by Repeatable Battery for the Assessment of Neuropsychological Status | 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. | 4 weeks |
| 40384005 | Derived | Zhang L, Guo Z, Han Y, Yan H, Lv D, Yao P, Zhao J, Chen L, Guo W. Altered cerebral functional activity and its associated genetic profiles underlying chronic insomnia disorder before and after treatment. World J Biol Psychiatry. 2025 Jun;26(5):211-223. doi: 10.1080/15622975.2025.2503938. Epub 2025 May 18. |
| D011725 |
| Pyridines |