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Clinical efficacy and gut flora modulation of acupuncture in Insomnia based on resting state functional magnetic resonance imaging

Clinical efficacy and gut flora modulation of acupuncture in Insomnia based on resting state functional magnetic resonance imaging

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200065985
Enrollment
Unknown
Registered
2022-11-21
Start date
2022-12-01
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

insomnia

Interventions

Acupuncture group:acupuncture treatment
Western medicine group:Take estazolam tablets orally before going to bed
Healthy people group:No treatment, only one functional magnetic resonance scan.

Sponsors

Shandong Provincial Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Conform to the diagnostic criteria of insomnia; 2. Aged 18-70 years, male or female; 3. PSQI score >= 7; 4. Have not taken any neuropsychiatric drugs or received acupuncture treatment in the past month; 5. VAS score >= 5; 6. Know relevant matters, cooperate with acupuncture treatment, voluntarily participate in this trial and sign the informed consent form; 7. Right handed. Healthy people: Those with good physical condition, good sleep, right handedness, no organic or serious functional disease, no history of mental disease, and no contraindication to MRI. 1. Aged 18-70 years, male or female; 2. Right handed; 3. No acupuncture treatment has been carried out in the past month; 4. Those who voluntarily participate in this experiment and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women; 2. Temporary insomnia caused by taking drugs or environmental changes; 3. Insomnia caused by systemic diseases such as pain, fever, surgery and other external environmental interference factors; 4. Insomnia caused by taking psychoactive substances, such as heavy drinking, coffee, etc.; 5. Patients with serious mental illness; 6. Those who are easy to be infected or have a history of spontaneous bleeding tendency; 7. Patients with a history of serious primary diseases of cardiovascular, cerebrovascular, liver, kidney and hematopoietic systems; 8. Alcohol dependent patients; 9. There are metal, claustrophobia and other MRI contraindications in the body.

Design outcomes

Primary

MeasureTime frame
Pittsburgh sleep quality index, PSQI;Insomnia Severity Index, ISI;

Secondary

MeasureTime frame
Visual Analogue Scale/Score, VAS;SAS, Self-Rating Anxiety Scale;Self-rating Depression Scale, SDS;

Countries

China

Contacts

Public ContactBai Tianyu

Shandong Provincial Third Hospital

283799804@qq.com+86 15168879181

Outcome results

None listed

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