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

Phase

N/A

Condition

N/A

Treatment

Acupuncture

Clinical Study ID

NCT06782815

2024ZL531-primary insomnia

Ages 18-40
All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

In line with the diagnostic criteria of insomnia of liver depression and spleendeficiency 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 metfor inclusion in this study.

Exclusion

Exclusion Criteria:

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

Study Design

Acupuncture

January 01, 2024

December 31, 2026

Study 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.

Connect with a study center

The Third Affiliated Hospital of Zhejiang Chinese Medical University
HangZhou, Zhejiang 321000
China
Active - Recruiting

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