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Multimodal fMRI brain mechanism study of acupuncture EX-HN1 for chronic insomnia

Multimodal fMRI brain mechanism study of acupuncture EX-HN1 for chronic insomnia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064814
Enrollment
Unknown
Registered
2022-10-19
Start date
2022-11-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

chronic insomnia

Interventions

Single point treatment group:Acupuncture EX-HN1
Acupuncture EX-HN1 and matching points group:Acupuncture EX-HN1 and matching points
Drug control group:Sulforaphane (eszopiclone) tablets
Healthy control group:None

Sponsors

Guang'anmen Hospital China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 55 Years

Inclusion criteria

Inclusion criteria: The treatment group met the following 1,2,3,4,5,6,7 conditions; healthy subjects met 1,4,5,7 conditions: 1. Aged between 40 and 55 years, non-pregnant and lactating females; 2. Meeting the ICSD-3 diagnostic criteria: difficulty in falling asleep; difficulty in maintaining sleep; early awakening and difficulty in falling back asleep; 3. Insomnia of 3-6 months duration; no relevant treatment within the last 2 weeks; 4. Previous health, no major anxiety and depression and cognitive impairment, no history of psychiatric disorders, no myasthenia gravis, no tumor, no serious underlying pathology such as heart, liver and kidney; 5. No metal in the body and no contraindication to MRI; 6. In line with the TCM classification: liver qi stagnation, liver depression and spleen deficiency type insomnia. Symptoms: insomnia for a long time, difficulty in falling asleep, difficulty in falling asleep after waking up, tiredness and fatigue, irritability, irritability, dizziness or headache, drowsiness, abdominal fullness, bitterness in the mouth, sighing, dry or loose stools, thin or yellow tongue coating, teeth marks on the side, string or moist pulse; 7. Agree to sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Somatic diseases such as central nervous system disease, substance abuse, alcohol abuse, cardiovascular disease; 2. Other chronic diseases that may affect cognitive function; 3. History of mental illness and family history; 4. People with claustrophobia; people with metal residues in the body, deep vein placement, etc., who cannot perform MRI scans or affect image quality.

Design outcomes

Primary

MeasureTime frame
Brain function;Intracerebral metabolites;

Secondary

MeasureTime frame
Clinical scale;

Countries

China

Contacts

Public ContactLiu Chunling

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

emzlcl@163.com+86 13521369667

Outcome results

None listed

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