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Study on clinical effect and mechanism of acupuncture therapy for primary insomnia: 'soothing the liver and moving the spleen, regulating the ying and calming the mind'

Study on clinical effect and mechanism of acupuncture therapy for primary insomnia: 'soothing the liver and moving the spleen, regulating the ying and calming the mind'

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072229
Enrollment
Unknown
Registered
2023-06-07
Start date
2023-06-01
Completion date
Unknown
Last updated
2023-06-18

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

Conditions

primary insomnia

Interventions

acupuncture group:acupuncture
sham acupuncture group:sham acupuncture

Sponsors

Yueyang Integrative Medicine Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria for primary insomnia in the International Classification of Sleep Disorders (ICSD-3); (2) TCM syndrome differentiation is the type of liver depression and spleen deficiency; (3) The standard score of the subject's Anxiety Self-rating Scale (SAS) was <70, and the standard score of the Self-rating Depression Scale (SDS) was <0.7; (4) Patients who have taken Western medicine for more than 3 months with poor effect or have not taken medicine; (5) Age =18, age =65, gender no limit; (6) Understand and agree to participate in this study and sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients with severe damage of heart, liver and kidney function, diseases of blood and respiratory system and severe mental illness; (2) Those with infectious diseases such as liver disease and AIDS and those who have not recovered from severe trauma; (3) those with severe digestive diseases and severe malnutrition; (4) Pregnant or lactating women; (5) Patients with acupuncture contraindications, such as metal allergy, severe skin ulceration, and other patients assessed by researchers as unsuitable for acupuncture; (6) Did not participate in other clinical studies within 3 months.

Design outcomes

Primary

MeasureTime frame
Insomnia Severity Index;

Secondary

MeasureTime frame
pittsburgh sleep quality index,PSQI;self-rating anxiety scale,SAS;Self-Rating Depression, SDS;TCM Symptom and syndrome Scale;PSG;ET;fMRI;

Countries

China

Contacts

Public ContactZhao Na

Yueyang Integrative Medicine Hospital Affiliated to Shanghai University of Traditional Chinese

zhaoziqing1988@126.com+86 188 1793 9784

Outcome results

None listed

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