Acupoint Selection Based on Meridian Theory in Primary Insomnia of Liver Depression and Spleen Deficiency Type

Chuanlong Zhou

Status: Enrolling

Conditions: Primary Insomnia

Treatments: Device: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT06782815

2024ZL531-primary insomnia

Details and patient eligibility

About

The classical literature combined with modern medicine to select acupoints, in order to intervene in the autonomic nerve function of the superior cervical sympathetic ganglion as an opportunity, put forward the meridian acupoints mainly to reconcile the head orifices Ying Wei, acupuncture treatment of primary insomnia clinical research. Heart rate variability ( HRV ), Pittsburgh sleep quality index ( PSQI ), polysomnography ( PSG ) and the MOS item short from health survey ( SF-36 ) were observed. Insomnia Severity Index ( ISI ), Dysfunctional Beliefs and Attitudes about Sleep Scale 16 ( DBAS-16 ), GABA, Glx and other secondary indicators were used to clarify the clinical short-term and long-term efficacy of different acupoints in the treatment of patients with primary insomnia and the intervention effect on HRV.

Full description

In this randomized controlled trial, 96 patients with insomnia of liver depression and spleen deficiency type were selected from the Third Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine. All patients will be randomly assigned to the control group or the acupuncture group.

MAIN OUTCOME MEASURES : Pittsburgh Sleep Quality Index ( PSQI ) was used to measure sleep quality, and 36-Item Short Form Health Survey ( SF-36 ) was used to measure quality of life. Secondary outcomes included the Insomnia Severity Index ( ISI ), Sleep Dysfunction Beliefs and Attitudes Scale 16, DBAS-16, GABA and Glx.

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• In line with the diagnostic criteria of insomnia of liver depression and spleen deficiency type in traditional Chinese medicine :
• In line with the Western diagnostic criteria for insomnia ;
• 18 ≤ age ≤ 40 years old, male or female ;
• patients with a course of more than two weeks ; Note: The above criteria must be met for inclusion in this study.

Exclusion criteria

• Insomnia caused by a variety of organic diseases, neurological or psychiatric disorders
• Pregnancy, lactation or drug allergy
• There are more serious primary diseases such as cardiovascular and cerebrovascular diseases, gastrointestinal diseases, endocrine system diseases, or psychiatric patients.
• Patients with coagulation dysfunction and bleeding tendency.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

96 participants in 2 patient groups

Control group

Sham Comparator group

Description:

This group will include 48 patients. Conventional acupuncture, patients take the supine position

Treatment:

Device: Acupuncture

Device: Acupuncture

Acupuncture group

Experimental group

Description:

This group will include 48 patients. The patient was placed in a supine position.

Treatment:

Device: Acupuncture

Device: Acupuncture