Clinical efficacy evaluation and RS-fMRI related mechanism of acupuncture at Xingan Yuyuan point in the treatment of insomnia of heart type caused by liver fire

Phase 1

Recruiting

• Conditions: insomnia

• Registration Number: ITMCTR2200006819
• Lead Sponsor: Yueyang Hospital of Integrated Traditional Chinese and Western Medicin, Shanghai University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 March 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Aged between 18 and 65 years (no gender limitation).
2.Comply with the diagnostic criteria for chronic insomnia in ICSD-3.
3.Comply with the diagnostic criteria for chronic insomnia in traditional Chinese Medicine and syndrome differentiation belongs to liver fire disturbing heart.
4.Patients has been taking sedative and hypnotic drugs regularly for more than 3 months or has not taken sedation before entering the study.
5.Pittsburgh Sleep Therapy Index (PSQI)>5 points.
6.Voluntarily participate in this study and sign the informed consent.
7.Patients has not received acupuncture treatment yet.

Exclusion Criteria

1. Patients with severe impairment of heart, liver and kidney function, hematological and respiratory diseases, and mental disorders diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders.
2. Patients are identified as other sleep disorders rather than primary insomnia according to Semi-structured clinical interview.
3. Patients with liver disease, tuberculosis, AIDS and other infectious diseases.
4. Patients with severe digestive diseases and malnutrition.
5. Pregnant or lactating women.
6. Patients with severe trauma or other patients who are not suitable for acupuncture, such as allergic constitution and severe skin diseases.
7. Polysomnography (PSG) showed apnea hypopnea index (AHI) = 11 or periodic limb movements with arousal = 15.
8. Beck Depression Inventory 17-item version score =17.
9. Patients who have participated or are currently participating in other clinical trials within the last 3 months.
10. Contraindications to magnetic resonance imaging: patients with metal implants or metal foreign bodies in the body, such as pacemakers, artificial metal heart valves, metal joints, metal implants, dentures, insulin pumps, or contraceptive devices for women.
11. Those who are afraid of needles or sick of needles.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fatigue Scale-14;Beck Anxiety Inventory;BOLD signal of multifunctional magnetic resonance imaging;Epworth Sleepiness Scale;Insomnia Severity Index;Blinding assessment;Pittsburgh sleep quality index;Beck Depression Inventory;