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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-10

Study Completion Date

2024-03-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Insomnia Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

suanzaoren decoction

Intervention Type DRUG

The Suanzaoren decoction is a Chinese herbal formula known for nourishing the blood, calming the mind, and nourishing the heart and liver

eszopiclone

Eszopiclone: Take 1mg nightly before bedtime.

Group Type ACTIVE_COMPARATOR

Eszopiclone 1 mg

Intervention Type DRUG

Eszopiclone is used in the treatment of various types of insomnia.

Interventions

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suanzaoren decoction

The Suanzaoren decoction is a Chinese herbal formula known for nourishing the blood, calming the mind, and nourishing the heart and liver

Intervention Type DRUG

Eszopiclone 1 mg

Eszopiclone is used in the treatment of various types of insomnia.

Intervention Type DRUG

Other Intervention Names

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Suan Zao Ren Tang Estorra

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No