Acupoint Selection Based on Meridian Theory in Primary Insomnia of Liver Depression and Spleen Deficiency Type
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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Acupuncture, Acupuncture.
- Who it may be relevant to
- Registry conditions: Primary Insomnia. Basic parameters: 18 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- 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.
Primary outcome measures
- Sleep quality measured by Pittsburgh sleep quality index ( PSQI) [Time frame: Before treatment, 4 weeks of treatment, and 4 weeks after the end of treatment, three time points were observed.]
- Quality of life measure by 36-item short form health survey（SF-36） [Time frame: Before treatment, 4 weeks of treatment, and 4 weeks after the end of treatment, three time points were observed.]
Secondary outcome measures (4)
- Insomnia Severity Index（ISI） [Time frame: Before treatment, 4 weeks of treatment, and 4 weeks after the end of treatment, three time points were observed.]
- Dysfunctional Beliefs and Attitudes about Sleep Scale 16，DBAS-16 (DBAS-16) [Time frame: Before treatment, 4 weeks of treatment, and 4 weeks after the end of treatment, three time points were observed.]
- GABA [Time frame: Before treatment, 4 weeks of treatment, and 4 weeks after the end of treatment, three time points were observed.]
- Glx [Time frame: Before treatment, 4 weeks of treatment, and 4 weeks after the end of treatment, three time points were observed.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The Third Affiliated Hospital of Zhejiang Chinese Medical University — Hangzhou
Identifiers
NCT: NCT06782815 · 2024ZL531-primary insomnia