Chronic Insomnia DisorderNCT06452953
Modified Suanzaoren Decoction Versus Eszopiclone for the Treatment of Chronic Insomnia Disorder
A study testing suanzaoren decoction and Eszopiclone 1 mg in people with Chronic Insomnia Disorder, run by Central South University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Insomnia Disorder
- What is being tested?
- suanzaoren decoction and Eszopiclone 1 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2020to 1 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Chronic Insomnia Disorder
- Being tested
- suanzaoren decoction, Eszopiclone 1 mg
- Keywords
- suanzaoren decoction, eszopiclone, polysomnography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
suanzaoren decoctionDrug
Also called Suan Zao Ren Tang
The Suanzaoren decoction is a Chinese herbal formula known for nourishing the blood, calming the mind, and nourishing the heart and liver
Eszopiclone 1 mgDrug
Also called Estorra
Eszopiclone is used in the treatment of various types of insomnia.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: suanzaoren decoction |
| eszopiclone | Active comparator | Eszopiclone: Take 1mg nightly before bedtime. Receives: Drug: Eszopiclone 1 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (4)
The sleep condition before and after treatment is reflected using polysomnography
Polysomnography is a comprehensive test used to diagnose sleep disorders. It records various body functions during sleep, including brain waves, eye movements, muscle activity, heart rhythm, and breathing patterns. This information helps clinicians evaluate sleep quality and diagnose sleep disorders such as sleep apnea, insomnia, and REM behavior disorder.
Measured: 4 weeks
The depression condition before and after treatment is evaluated by Hamilton Depression Rating scale
The Hamilton Depression Rating Scale is a widely used tool to measure the severity of depression in individuals. It consists of 17 items that assess various symptoms of depression, such as mood, guilt, suicidal thoughts, and sleep disturbances. Each item is scored based on the severity of the symptom, and the total score indicates the overall severity of depression, with higher scores indicating more severe depression.
Measured: 4 weeks
The anxiety condition before and after treatment is evaluated by Hamilton Anxiety Rating scale
The Hamilton Anxiety Rating Scale (HAM-A) is a widely used tool for assessing the severity of anxiety symptoms in individuals. It consists of 14 items that measure various aspects of anxiety, including psychological, physical, and behavioral symptoms.
Measured: 4 weeks
The cognition function before and after treatment is evaluated by Repeatable Battery for the Assessment of Neuropsychological Status
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) is a widely used neuropsychological assessment tool designed to evaluate cognitive function across various domains. It consists of 12 subtests that assess attention, language, visuospatial/constructional abilities, and immediate and delayed memory.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start10 Sep 2020
- Primary completion31 Oct 2023
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Insomnia DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Collaborators
- The Third Hospital of Inner Mongolia Autonomous Region
- Responsible party
- Principal investigator, Guo Wenbin, Central South University
- Investigators
- Wenbin Guo, Principal investigator, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06452953
- Sponsor's protocol ID
- 2019MS08099
- Status last verified
- Jun 2024
- First submitted
- 30 May 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guo Z, Zhang L, Han Y, Yan H, Yao P, Lv D, Yuan Y, Zhao J, Chen L, Guo W. Altered Effective Connectivity of Precuneus Subregions and Associated Gene Profiles in Chronic Insomnia Disorder Patients Before and After Treatment. Brain Behav. 2026 May;16(5):e71448. doi: 10.1002/brb3.71448.
PubMed 42157543Yao 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.
PubMed 40778328Zhang 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.
PubMed 40384005
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06452953
- Acronym / sponsor ID
- 2019MS08099
- Conditions
- Chronic Insomnia Disorder
- Keywords
- suanzaoren decoction, eszopiclone, polysomnography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Collaborators
- The Third Hospital of Inner Mongolia Autonomous Region
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| suanzaoren decoction | Experimental | Drug: suanzaoren decoctionThe 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. |
| eszopiclone | Active comparator | Drug: Eszopiclone 1 mgEszopiclone: Take 1mg nightly before bedtime. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| suanzaoren decoctionAlso: Suan Zao Ren TangThe Suanzaoren decoction is a Chinese herbal formula known for nourishing the blood, calming the mind, and nourishing the heart and liver | Drug | suanzaoren decoction |
| Eszopiclone 1 mgAlso: EstorraEszopiclone is used in the treatment of various types of insomnia. | Drug | eszopiclone |
Primary outcome
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.
4 secondary outcomes
The sleep condition before and after treatment is reflected using polysomnography
Time frame: 4 weeks
The depression condition before and after treatment is evaluated by Hamilton Depression Rating scale
Time frame: 4 weeks
The anxiety condition before and after treatment is evaluated by Hamilton Anxiety Rating scale
Time frame: 4 weeks
The cognition function before and after treatment is evaluated by Repeatable Battery for the Assessment of Neuropsychological Status
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Derived from this study: PubMed 42157543Guo Z, Zhang L, Han Y, Yan H, Yao P, Lv D, Yuan Y, Zhao J, Chen L, Guo W. Altered Effective Connectivity of Precuneus Subregions and Associated Gene Profiles in Chronic Insomnia Disorder Patients Before and After Treatment. Brain Behav. 2026 May;16(5):e71448. doi: 10.1002/brb3.71448.
- Derived from this study: PubMed 40778328Yao 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.
- Derived from this study: PubMed 40384005Zhang 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.
Related trials for Chronic Insomnia Disorder
Not yet recruitingPhase 2
A Study of Oral SOM001 as a Safe and Effective Treatment for Adults With Chronic Insomnia in a Randomized, Controlled, Dose-finding Study
Chronic Insomnia
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
Active, not recruiting
Health enSuite Insomnia: an App-based Treatment for Adult Chronic Insomnia
Insomnia
Not yet recruiting
Effects of Connective Tissue Massage in Patients With Chronic Insomnia
Chronic Insomnia
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wenbin Guo principal investigator
Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing suanzaoren decoction and Eszopiclone 1 mg in people with Chronic Insomnia Disorder, run by Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The improvement of insomnia before and after treatment was assessed using the Pittsburgh Sleep Quality Index (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06452953, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.