Acupuncture With Five Shu Points for Insomnia in Heart-Spleen Deficiency

Efficacy of Five Shu Point Acupuncture in the Treatment of Insomnia in Patients With Heart-Spleen Deficiency Pattern: A Randomized Controlled Trial

This study was designed as a randomized controlled trial (RCT) with a multicenter, single-blind methodology. Participants diagnosed with insomnia attributable to the Heart-Spleen Deficiency pattern, receiving treatment at the Ho Chi Minh City Hospital of Traditional Medicine and Hospital 1A, were randomly allocated into two groups.

Study Overview

• Status: Recruiting
• Conditions: Insomnia, Nonorganic
• Intervention / Treatment: Procedure: Acupuncture at Viet Nam MOH standard points plus Five Shu points; Procedure: Acupuncture at Viet Nam MOH standard points

Detailed Description

Background: Insomnia is a prevalent sleep disorder with considerable public health impact. Acupuncture based on Five Shu points, guided by Five Phase theory, represents a promising non-pharmacological approach for Heart-Spleen deficiency pattern insomnia. However, high-quality clinical evidence supporting its efficacy remains scarce, and studies conducted in Vietnamese populations are notably absent. This gap highlights the need for rigorous clinical investigation in this specific context.

Objectives: This trial aims to compare the efficacy of acupuncture at Five Shu points plus Viet Nam Ministry of Health (MOH) standard points versus Viet MOH standard points alone in improving sleep quality (PSQI) and alleviating TCM Heart-Spleen deficiency pattern-specific symptoms after 14 days, 28 days.

Study design: A multicenter, randomized, single-blind (assessor-blinded), active-controlled trial with two parallel arms. A total of 46 participants will be enrolled (23 per arm) based on sample size calculation.

Participants: Adults aged ≥18 years, meeting DSM-V criteria for chronic insomnia and TCM diagnostic criteria for Heart-Spleen deficiency pattern. Exclusion criteria include other sleep disorders, severe psychiatric illness, and use of psychotropic medications.

Interventions:

Experimental arm: Acupuncture at Viet Nam MOH standard points (PC6, SP6, ST36, BL15, SP3, BL17) plus Five Shu points (HT9, HT7, SP2, LR2). Needles retained for 30 minutes using tonifying technique, once daily, 5 consecutive days per week (Monday-Friday, with Saturday and Sunday rest), over a 28-day period, for a total of 20 acupuncture sessions.

Control arm: Same acupuncture at Viet Nam MOH standard points only, same schedule.

Both groups receive standardized sleep hygiene education.

Outcomes: The co-primary outcomes are: (1) change in PSQI global score from baseline to day 28, and (2) change in the TCM Heart-Spleen deficiency symptom scale score from baseline to day 28. The secondary outcome measure is adverse events related to acupuncture, which includes the recording and analysis of any adverse events (such as pain, bleeding, infection, dizziness, or other unexpected reactions) occurring during the 28-day intervention period, from day 1 to day 28 of the treatment

Randomization and blinding: Central computer-generated randomization (1:1). Patients cannot be blinded due to nature of acupuncture, but outcome assessors and data analysts will be blinded to group allocation.

Statistical analysis: Intention-to-treat analysis. Between-group differences will be analyzed using t-test or Mann-Whitney U test as appropriate. A P-value < 0.05 will be considered statistically significant.

Safety: All adverse events will be documented and managed according to standard operating procedures.

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nguyen Xuan Ngo, Doctor; Phone Number: +84 946043639; Email: nguyengo.nn@gmail.com

Study Locations

• Vietnam
  • Ho Chi Minh City, Vietnam
    • Recruiting
    • University of Medicine and Pharmacy at Ho Chi Minh City
  • Ho Chi Minh City, Vietnam
    • Recruiting
    • Ho Chi Minh City Hospital of Traditional Medicine (179-187 Nam Ky Khoi Nghia Street, Xuan Hoa Ward, Ho Chi Minh City)
    • Contact: Nguyen Xuan Ngo, Doctor; Phone Number: +84 946043639; Email: nguyengo.nn@gmail.com
  • Ho Chi Minh City, Vietnam
    • Recruiting
    • Hospital 1A (1A Ly Thuong Kiet Street, Tan Son Nhat Ward, Ho Chi Minh City)
    • Contact: Nguyen Xuan Ngo, Doctor; Phone Number: +84 946043639; Email: nguyengo.nn@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients aged 18 years or older who voluntarily consent to participate in the study.
• Patients who have never used or have discontinued insomnia medication within 2 weeks prior to study enrollment.
• Patients meeting the diagnostic criteria for insomnia according to the DSM-V of the American Psychiatric Association, specifically as follows:

A. The patient complains about sleep quantity or quality, including one or more of the following symptoms: difficulty initiating sleep; difficulty maintaining sleep, characterized by frequent awakenings or trouble returning to sleep after awakening; early morning awakening with inability to return to sleep.

B. Sleep difficulty occurs for at least 3 months. C. Sleep disturbance causes significant distress or impairment in social, occupational, educational, academic, behavioral, or other important areas of functioning.

D. Sleep difficulty occurs at least 3 nights per week. E. Sleep difficulty occurs despite adequate opportunity for sleep. F. Insomnia is not better explained by another sleep disorder (e.g., narcolepsy, breathing-related sleep disorder, circadian rhythm sleep disorder).

G. Co-existing mental disorders or medical conditions do not adequately explain the predominant complaint of insomnia.

H. Insomnia is not attributable to the physiological effects of a substance.

• Patients who are able to understand Vietnamese.
• Patients meeting the diagnostic criteria for Heart-Spleen dual deficiency syndrome according to Jing Lv, requiring the presence of mandatory symptoms + 2 primary symptoms + 2 secondary symptoms + tongue and pulse findings, specifically:

Mandatory symptoms

• Sleeplessness throughout the night, or light sleep with frequent awakening; fragmented sleep.
• Frequent nightmares.
• Early morning awakening with inability to fall back asleep.

Primary symptoms

Palpitations, forgetfulness. Mental fatigue, poor appetite. Pale, unhealthy complexion. Secondary symptoms

Dizziness, blurred vision. Weakness of limbs. Abdominal distension, loose stools. Tongue and pulse findings

Pale tongue with thin white coating. Thin, weak, forceless pulse.

Exclusion Criteria:

• Patients diagnosed with other sleep disorders such as sleep apnea syndrome or narcolepsy.
• Patients previously diagnosed with neurological or psychiatric disorders (e.g., anxiety disorder, autism spectrum disorder, depression, obsessive-compulsive disorder, rapid eye movement sleep behavior disorder) prior to study enrollment.
• Patients currently using antidepressants or psychiatric medications.
• Patients participating in other clinical trials involving behavioral, psychological, or complementary medical interventions during the study period.
• The patient no longer agrees to continue participation.
• Occurrence of uncomfortable symptoms during the study, such as needle syncope, nausea, headache, dizziness, sweating, etc.
• Significant worsening of the condition or development of new complications.
• Non-adherence to the treatment protocol, making continuation impossible.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupuncture was administered at acupoints standardized by the Vietnam Ministry of Health; Participants receive all acupoints from the Vietnam MOH protocol (PC6, SP6, ST36, BL15, SP3, BL17) plus additional Five Shu (Wǔ Shū) points selected according to Five Phase (Wǔ Xíng) correspondences: HT9 (Shaochong), HT7 (Shenmen), SP2 (Dadu), LR2 (Xingjian). Needles retained for 30 minutes using tonifying technique, once daily, 5 consecutive days per week (Monday-Friday, with Saturday and Sunday rest), over a 28-day period, for a total of 20 acupuncture sessions. All participants receive identical sleep hygiene psychoeducation as control group. Primary outcomes: PSQI and TCM Heart-Spleen Deficiency symptom scale at 14 days, 28 days post-intervention.	Procedure: Acupuncture at Viet Nam MOH standard points plus Five Shu points; Experimental arm: Acupuncture at Viet Nam MOH standard points (PC6, SP6, ST36, BL15, SP3, BL17) plus Five Shu points (HT9, HT7, SP2, LR2). Needles retained for 30 minutes using tonifying technique, once daily, 5 consecutive days per week (Monday-Friday, with Saturday and Sunday rest), over a 28-day period, for a total of 20 acupuncture sessions. All participants receive identical sleep hygiene psychoeducation.
Active Comparator: Control group: Standard Acupuncture ( Vietnam MOH Protocol); Participants receive acupuncture at acupoints standardized by the Vietnam Ministry of Health (MOH) for insomnia with Heart-Spleen Deficiency pattern. Points: PC6 (Neiguan), SP6 (Sanyinjiao), ST36 (Zusanli), BL15 (Xinshu), SP3 (Taibai), BL17 (Geshu). Needles retained for 30 minutes using tonifying technique, once daily, 5 consecutive days per week (Monday-Friday, with Saturday and Sunday rest), over a 28-day period, for a total of 20 acupuncture sessions. All participants receive standardized psychoeducation on sleep hygiene, lifestyle modifications, and pre-sleep behavioral routines. Outcome measures: PSQI and TCM pattern-specific symptom scale at 14 days, 28 days post-intervention.	Procedure: Acupuncture at Viet Nam MOH standard points; Control arm: Same acupuncture at VIet Nam MOH standard points only, same schedule. All participants receive identical sleep hygiene psychoeducation as Intervention group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia Associated with Heart-Spleen Deficiency	Title: Pittsburgh Sleep Quality Index (PSQI) global score Unit of Measure: points on a scale Scale Range: 0 to 21 Direction: Lower score indicates better sleep quality	every 14 days, 28 days post-intervention
Insomnia Associated with Heart-Spleen Deficiency	Title: TCM Heart Spleen Deficiency Symptom Scale (based on Jing Lv, 2016) Unit of Measure: points on a scale Scale Range: 0 to 39 Direction: Higher score indicates more severe symptoms	Every 14 days, 28 days post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events related to acupuncture	Recording and analysis of any adverse events (e.g., pain, bleeding, infection, dizziness, or other unexpected reactions) related to acupuncture during the 28-day intervention period	From day 1 to day 28 of intervention

Collaborators and Investigators

• Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City

Publications and helpful links

General Publications

• Zhang KQ, Zhao ZH, et al. Analysis of the connotation and clinical application rules of "Shu" (俞)-named acupoints on the whole body. Journal of Traditional Chinese Medicine and Pharmacy. 2023;29(10):103-106.
• Yuan CX. Clinical study of abdominal acupuncture for the treatment of insomnia of heart-spleen deficiency type [PhD thesis]. [Beijing]; 2020.
• Liu C. Acupuncture at five-shu acupoints for insomnia due to heart-kidney disharmony: a clinical analysis of 50 cases. Chronic Pathematology J. 2020;21(12):1788-1791.
• Shu RJ. Theoretical discussion and preliminary clinical application of Five-element acupuncture in the treatment of skin diseases from the perspective of "Shen" [PhD thesis]. 2018.
• Wang W. Five-element acupuncture: a mind-body therapy originating from China. Science & Technology Review. 2019;37(15):91-97.
• Zhang J, Lu L, Li Y, et al. A randomized controlled study of water-acupoint embedding therapy combined with herb-separated moxibustion for the treatment of obesity complicated with hyperlipidemia due to spleen deficiency and dampness stagnation. Sichuan Traditional Chinese Medicine. 2017;35(5):189-192.
• Lv J. A preliminary study on the distribution of Traditional Chinese Medicine (TCM) syndrome types and the differences in sleep status between syndrome types in short-term insomnia [Master's thesis]. 2016.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 10, 2026

Study Registration Dates

• First Submitted: April 9, 2026
• First Submitted That Met QC Criteria: April 19, 2026
• First Posted (Actual): April 22, 2026

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: insomnia; acupuncture; Five-Shu acupoints; Heart-Spleen deficiency
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 606/DHYD - HDDD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared because all information provided by participants is used solely for research purposes, coded as ID numbers, stored on a password-protected personal computer, and accessible only to the principal investigator. After study completion, data will be destroyed according to regulations, as stated in the ethics and confidentiality section of the study protocol.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No