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

NCT07544082 | Recruiting

• 1 other identifier: 606/DHYD - HDDD
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Insomnia, Nonorganic

Keywords

Five-Shu acupoints; insomnia; acupuncture; Heart-Spleen deficiency

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Adverse events related to acupuncture

  From day 1 to day 28 of intervention

Study Arms (2)

Acupuncture was administered at acupoints standardized by the Vietnam Ministry of Health

EXPERIMENTAL

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

Control group: Standard Acupuncture ( Vietnam MOH Protocol)

ACTIVE COMPARATOR

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

Interventions

Acupuncture at Viet Nam MOH standard points plus Five Shu points PROCEDURE

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.

Acupuncture was administered at acupoints standardized by the Vietnam Ministry of Health

Acupuncture at Viet Nam MOH standard points PROCEDURE

Control arm: Same acupuncture at VIet Nam MOH standard points only, same schedule. All participants receive identical sleep hygiene psychoeducation as Intervention group

Control group: Standard Acupuncture ( Vietnam MOH Protocol)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (3)

Ho Chi Minh City Hospital of Traditional Medicine (179-187 Nam Ky Khoi Nghia Street, Xuan Hoa Ward, Ho Chi Minh City)

Ho Chi Minh City, Vietnam

RECRUITING

Hospital 1A (1A Ly Thuong Kiet Street, Tan Son Nhat Ward, Ho Chi Minh City)

Ho Chi Minh City, Vietnam

RECRUITING

University of Medicine and Pharmacy at Ho Chi Minh City

Ho Chi Minh City, Vietnam

RECRUITING

Related Publications (7)

• 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.

  BACKGROUND

• Yuan CX. Clinical study of abdominal acupuncture for the treatment of insomnia of heart-spleen deficiency type [PhD thesis]. [Beijing]; 2020.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• Wang W. Five-element acupuncture: a mind-body therapy originating from China. Science & Technology Review. 2019;37(15):91-97.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Nguyen Xuan Ngo, Doctor

CONTACT

+84 946043639; nguyengo.nn@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: For study participants: Patients are aware whether they belong to the intervention group or the control group. For the outcome assessor: The data assessor is an individual who does not participate in the treatment process and is not provided with any information regarding group allocation throughout the study. They are assigned to evaluate the PSQI scores and the Heart-Spleen deficiency syndrome symptoms in order to ensure objectivity and reliability of the outcome data
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Control Group: Acupuncture was administered at acupoints standardized by the Vietnam Ministry of Health for the management of insomnia associated with the Heart-Spleen Deficiency pattern, comprising: Nèiguān (PC6), Sānyīnjiāo (SP6), Zúsānlǐ (ST36), Xīnshū (BL15), Tàibái (SP3), and Géshū (BL17). Intervention Group: Acupuncture was administered at the aforementioned Ministry of Health-prescribed acupoints, supplemented by the selection of Five Shu Points in accordance with the principles of Five Phase correspondences, including: Shàochōng (HT9), Shénmén (HT7), Dàdū (SP2), and Xíngjiān (LR2).

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 22, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 10, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

VN (3)