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

Phase 1

Recruiting

• Conditions: insomnia

• Registration Number: ITMCTR1900002397
• Lead Sponsor: Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,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: 20 February 2023

Recruitment & Eligibility

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

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

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;

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Beck Depression Inventory;TCM syndrome scale;Insomnia Severity Index; Pittsburgh Sleep Quality Index ;

Secondary Outcome Measures

Name	Time	Method
PSG;Beck Anxiety Inventory;