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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 85
- Locations
- 1
- Primary Endpoint
- The improvement of insomnia before and after treatment was assessed using the Pittsburgh Sleep Quality Index
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: suanzaoren decoction (Drug)
eszopiclone
Eszopiclone: Take 1mg nightly before bedtime.
Intervention: Eszopiclone 1 mg (Drug)
Outcomes
Primary Outcomes
The improvement of insomnia before and after treatment was assessed using the Pittsburgh Sleep Quality Index
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.
Secondary Outcomes
- 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)
Investigators
Guo Wenbin
Professor of Psychiatry Department of Psychiatry of the Second Xiangya Hospital, Central South University
Central South University