Modified Suanzaoren Decoction Versus Eszopiclone for the Treatment of Chronic Insomnia Disorder

Central South University

Status: Completed

Conditions: Chronic Insomnia Disorder

Treatments: Drug: Eszopiclone 1 mg; Drug: suanzaoren decoction

Study type: Interventional

Funder types: Other

Identifiers

NCT06452953

2019MS08099

Details and patient eligibility

About

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.

Full 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.

Enrollment: 85 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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85 participants in 2 patient groups

suanzaoren decoction

Experimental group

Description:

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.

Treatment:

Drug: suanzaoren decoction

eszopiclone

Active Comparator group

Description:

Eszopiclone: Take 1mg nightly before bedtime.

Treatment:

Drug: Eszopiclone 1 mg