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

NCT06782815 | Recruiting DMC

• 1 other identifier: 2024ZL531-primary insomnia
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Insomnia

Keywords

Liver stagnation and spleen deficiency type insomnia; Acupuncture; Randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• Sleep quality measured by Pittsburgh sleep quality index ( PSQI)

  The patients will be assessed by PSQI Chinese fixed questionnaire at each observation point and the clinical efficacy will be observed.It consists of 19 self-evaluation and 5 other-evaluation items. Only 19 self-evaluation questions are scored, and 19 self-evaluation questions are composed of 7 factors, each factor consists of 7 factors of 0-3 points. '0 ' refers to no difficulty, ' 3 ' refers to very difficult. The total score of ' 21 ' refers to very difficult in all respects. The sum of all factor scores constitutes the total score of the 0-21 scale. The reference boundary value of adult sleep quality problems in China : poor sleep quality : PSQI ≥ 8 ; good sleep quality : PSQI ≤ 7 ; the higher the score, the worse the sleep quality.

  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）

  The patients will be evaluated by SF-36 scale at each observation point. The SF-36 scale is a general scale developed by the American Medical Research Group to evaluate the quality of life. It is widely recognized and widely used in the world. This scale has eight dimensions to evaluate health-related quality of life ( HRQOL ), which belong to two categories of physical health and mental health, namely physiological function ( PF ), role physical ( RP ), bodily pain ( BP ), general health ( CH ), vitality ( VT ), social function ( SF ), role emotional ( RE ), mental health ( MH ). In addition, the SF-36 scale also includes another indicator - health change ( HT ), which is used to evaluate health changes over the past year.Add the scores of each item to the actual score, and then calculate the final score RP according to the following formula. The higher the RP score, the better the health status.

  Before treatment, 4 weeks of treatment, and 4 weeks after the end of treatment, three time points were observed.

Secondary Outcomes (4)

• Insomnia Severity Index（ISI）

  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)

  Before treatment, 4 weeks of treatment, and 4 weeks after the end of treatment, three time points were observed.

• GABA

  Before treatment, 4 weeks of treatment, and 4 weeks after the end of treatment, three time points were observed.

• Glx

  Before treatment, 4 weeks of treatment, and 4 weeks after the end of treatment, three time points were observed.

Study Arms (2)

Control group

SHAM COMPARATOR

This group will include 48 patients. Conventional acupuncture, patients take the supine position

Device: Acupuncture

Acupuncture group

EXPERIMENTAL

This group will include 48 patients. The patient was placed in a supine position.

Device: Acupuncture

Interventions

Acupuncture DEVICE

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.

Control group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 ;
• ≤ age ≤ 40 years old, male or female ;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chuanlong Zhou: lead

Study Sites (1)

The Third Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 321000, China

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Central Study Contacts

Zhou CL Zhou Chuanlong

CONTACT

15868486255; 471388079@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Chief Chinese Physician

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: January 20, 2025
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)