NCT06782815

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Chuanlong Zhou · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Insomnia

Interventions

Type	Name	Description
DEVICE	Acupuncture	acupuncture Baihui, Sishencong ; acupuncture bilateral Qimen, Zhangmen, Hegu, Taichong, reinforcing and reducing, until the acid swelling is obvious,stopped ferforming acupuncture, the needle was retained for 30 min.
DEVICE	Acupuncture	（1）Acupuncture bilateral Tianrong points, obliquely 45 ± 5 ° backward, 1-1.5 inch deep, reinforcing and reducing horizontally, and stop the needle when the auricle has a heat sensation ; （2）Acupuncture at bilateral Tianyou points, pointing to the tip of the nose, with a depth of 0.5-1 inches, flat reinforcing and reducing, until the sense of soreness and distension obviously stops, and the needle is retained for 30 minutes.

Timeline

• Start date: 2024-01-01
• Primary completion: 2026-12-30
• Completion: 2026-12-31
• First posted: 2025-01-20
• Last updated: 2025-02-11

Locations

1 site across 1 country: China