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

NCT06452953 | Completed

• 1 other identifier: 2019MS08099
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Insomnia Disorder

Keywords

suanzaoren decoction; eszopiclone; polysomnography

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• 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

• 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

Study Arms (2)

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.

Drug: suanzaoren decoction

eszopiclone

ACTIVE COMPARATOR

Eszopiclone: Take 1mg nightly before bedtime.

Drug: Eszopiclone 1 mg

Interventions

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

Also known as: Suan Zao Ren Tang

suanzaoren decoction

Eszopiclone 1 mg DRUG

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

Also known as: Estorra

eszopiclone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central South University: lead
• The Third Hospital of Inner Mongolia Autonomous Region: collaborator

Study Sites (1)

The Second Xiangya Hospital of Central South University

Changsha, China

Location

Related Publications (2)

• 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.

  PMID: 40778328 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.

  PMID: 40384005 DERIVED

MeSH Terms

Interventions

Eszopiclone

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Pyridines

Study Officials

• Wenbin Guo

  Central South University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry Department of Psychiatry of the Second Xiangya Hospital, Central South University

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 11, 2024
• Study Start: September 10, 2020
• Primary Completion: October 31, 2023
• Study Completion: March 1, 2024
• Last Updated: June 11, 2024

Record last verified: 2024-06

Locations

CN (1)