Clinical trial NCT06782815: Acupoint Selection Based on Meridian Theory in Primary Insomnia of Liver Depression and Spleen Deficiency Type
Official title: Study on the Curative Effect and Autonomic Nerve Function of Primary Insomnia Patients with Liver Depression and Spleen Deficiency Type Based on Acupoint Selection of Meridian Theory
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Primary Insomnia
Keywords: Liver stagnation and spleen deficiency type insomnia
Acupuncture
Randomized controlled trial
Lead sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
First posted: 2025-01-20
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sleep quality measured by Pittsburgh sleep quality index ( PSQI)
timeFrame: Before treatment, 4 weeks of treatment, and 4 weeks after the end of treatment, three time points were observed.
measure: Quality of life measure by 36-item short form health survey（SF-36）
timeFrame: Before treatment, 4 weeks of treatment, and 4 weeks after the end of treatment, three time points were observed.
Secondary outcomes:
measure: Insomnia Severity Index（ISI）
timeFrame: Before treatment, 4 weeks of treatment, and 4 weeks after the end of treatment, three time points were observed.
measure: Dysfunctional Beliefs and Attitudes about Sleep Scale 16，DBAS-16 (DBAS-16)
timeFrame: Before treatment, 4 weeks of treatment, and 4 weeks after the end of treatment, three time points were observed.
measure: GABA
timeFrame: Before treatment, 4 weeks of treatment, and 4 weeks after the end of treatment, three time points were observed.
measure: Glx
timeFrame: Before treatment, 4 weeks of treatment, and 4 weeks after the end of treatment, three time points were observed.
Other outcomes:
Locations:
city: HangZhou
country: China
facility: The Third Affiliated Hospital of Zhejiang Chinese Medical University
state: Zhejiang
Study officials:
References: