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Clinical Efficacy and fMRI Study of 'Reducing South and Reinforcing North' Acupuncture Treatment of Disharmony of the Heart and Kidney Insomnia

Clinical Efficacy and fMRI Study of 'Reducing South and Reinforcing North' Acupuncture Treatment of Disharmony of the Heart and Kidney Insomnia

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023787
Enrollment
Unknown
Registered
2019-06-12
Start date
2019-05-20
Completion date
Unknown
Last updated
2019-06-17

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

Conditions

insomnia

Interventions

Experimental group:Acupuncture
Control group:Sham acupuncture

Sponsors

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 74 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-74 years old male and female; 2. Comply with the diagnostic criteria for chronic insomnia in ICSD-3; 3. Comply with the diagnosis of innocent Chinese medicine, syndrome differentiation belongs to the type of disharmony of the heart and kidney insomnia; 4. Stable sedative and hypnotic drugs for more than 3 months before entering the study or not taking the drug; 5. Pittsburgh Sleep Therapy Index (PSQI) > 5 points.

Exclusion criteria

Exclusion criteria: 1. Patients with severe heart, liver and kidney function damage, as well as blood and respiratory diseases and diagnosed as mentally ill according to the Diagnostic and Statistical Manual of Mental Disorders; 2. Semi-structured clinical interviews to determine that the patient is in other sleep disorders rather than primary insomnia; 3. Patients with infectious diseases such as liver disease, tuberculosis and AIDS; 4. Those with severe digestive diseases and severe malnutrition; 5. Women during pregnancy or lactation;

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index ;Insomnia Severity Index;TCM syndrome scale;Beck Depression Inventory;

Secondary

MeasureTime frame
PSG;Beck Anxiety Inventory;

Countries

China

Contacts

Public ContactYun-fei Chen

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine

icyf1968@163.com+86 18930568221

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 14, 2026