Actively Recruiting
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
Led by Chuanlong Zhou · Updated on 2025-02-11
96
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the use of acupuncture based on meridian theory to treat primary insomnia associated with liver depression and spleen deficiency. This randomized controlled trial aims to clarify the short-term and long-term effects of different acupoint selections on sleep quality, autonomic nerve function, and quality of life. The study observes indicators such as heart rate variability, Pittsburgh Sleep Quality Index, polysomnography, and various scales measuring insomnia severity and beliefs about sleep. Participants are randomly assigned to one of two groups: a control group receiving conventional acupuncture or an experimental group receiving acupuncture at specific acupoints including Baihui, Sishencong, Qimen, Zhangmen, and others. Treatment involves needle insertion with specific techniques and durations, with needles retained for 30 minutes. Both groups receive acupuncture while in a supine position. Throughout the study, participants undergo assessments before treatment, after 4 weeks of treatment, and 4 weeks post-treatment. Evaluations include sleep quality using the Pittsburgh Sleep Quality Index, quality of life via the SF-36 survey, and secondary measures such as the Insomnia Severity Index, DBAS-16, and biochemical markers GABA and Glx. The study uses double blinding and randomized allocation to compare the effects of acupuncture at different points on insomnia symptoms and autonomic function.
CONDITIONS
Brief Title
Acupoint Selection Based on Meridian Theory in Primary Insomnia of Liver Depression and Spleen Deficiency Type
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meet diagnostic criteria for insomnia of liver depression and spleen deficiency type in traditional Chinese medicine
- Meet Western diagnostic criteria for insomnia
- Age between 18 and 40 years, any gender
- Have had insomnia symptoms for more than two weeks
You will not qualify if you...
- Insomnia caused by organic diseases, neurological or psychiatric disorders
- Pregnancy, lactation, or drug allergy
- Serious primary diseases such as cardiovascular, cerebrovascular, gastrointestinal, endocrine, or psychiatric conditions
- Coagulation dysfunction or bleeding tendency
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive acupuncture treatment based on meridian theory for primary insomnia of liver depression and spleen deficiency type.
Weekly visits for 4 weeks
Duration - 4 weeks
Participants are monitored for sleep quality and quality of life after the end of treatment.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
The Third Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, China, 321000
Actively Recruiting
Research Team
Z
Zhou CL Zhou Chuanlong
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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