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Based on cognitive neuropsychology, explore the mechanism of fMRI/ERP bimodal brain network in the treatment of primary insomnia with Chaihu Keel Oyster Decoction

Based on cognitive neuropsychology, explore the mechanism of fMRI/ERP bimodal brain network in the treatment of primary insomnia with Chaihu Keel Oyster Decoction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200006593
Enrollment
Unknown
Registered
2022-09-13
Start date
2022-09-13
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

insomnia

Interventions

control group:basic treatment
intervention group:basic treatment+decoction

Sponsors

Jiangsu Province Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Accord with the diagnosis of primary chronic insomnia; 2. PSQI score = 7; 3. Age 20-60 years old; 4. Not taking sedative and hypnotic drugs within a week, and not taking antidepressants and antipsychotics within a month. No psychoactive substances such as alcohol, coffee and cigarettes were ingested within 2 hours before the examination; 5. Clear mind, no other cognitive impairment, and can tolerate 30 minutes of magnetic resonance examination; 6. Sign informed consent according to ethical requirements.

Exclusion criteria

Exclusion criteria: 1. Abnormal binocular vision (or corrected vision) and hearing; 2. History of other mental diseases (depression, generalized anxiety disorder, panic disorder, bipolar disorder, mania, schizophrenia, etc.), HAMD>7, HAMA=7; 3. Other sleep disorders, such as sleep apnea, restless legs syndrome, etc; 4. Severe depression with suicidal tendency; 5. Serious physical diseases (thyroid disease, serious heart disease, malignant tumor, etc.); 6. History of alcohol, coffee, drug abuse, serious head injury and surgery; 7. Daytime obvious pathological sleepiness; 8. Night shift, jet lag, lactation and other circadian sleep rhythm disorders.

Design outcomes

Primary

MeasureTime frame
PSQI;

Secondary

MeasureTime frame
MoCA;MMSE;

Countries

China

Contacts

Public ContactDan Zhu
danselinazhu@126.com+8613813945115

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026