Clinical trial NCT06452953: Modified Suanzaoren Decoction Versus Eszopiclone for the Treatment of Chronic Insomnia Disorder
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Insomnia Disorder
Keywords: suanzaoren decoction
eszopiclone
polysomnography
Lead sponsor: Central South University
Sponsor class: OTHER
Collaborators: name: The Third Hospital of Inner Mongolia Autonomous Region
First posted: 2024-06-11
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The improvement of insomnia before and after treatment was assessed using the Pittsburgh Sleep Quality Index
timeFrame: 4 weeks
Secondary outcomes:
measure: The sleep condition before and after treatment is reflected using polysomnography
timeFrame: 4 weeks
measure: The depression condition before and after treatment is evaluated by Hamilton Depression Rating scale
timeFrame: 4 weeks
measure: The anxiety condition before and after treatment is evaluated by Hamilton Anxiety Rating scale
timeFrame: 4 weeks
measure: The cognition function before and after treatment is evaluated by Repeatable Battery for the Assessment of Neuropsychological Status
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
Study officials:
affiliation: Central South University
name: Wenbin Guo
role: PRINCIPAL_INVESTIGATOR
References: