Acupuncture using Five Shu points for Heart-Spleen deficiency insomnia

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

This test will see if adding Five Shu point acupuncture to Vietnam's standard acupuncture helps adults with chronic insomnia from Heart-Spleen deficiency sleep better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 46 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City (other)
• Locations: 3 sites (Ho Chi Minh City and 2 other locations)
• Trial ID: NCT07544082 on ClinicalTrials.gov

What this trial studies

This randomized, multicenter, single-blind trial will enroll 46 adults with DSM‑V chronic insomnia and TCM Heart‑Spleen deficiency at two Ho Chi Minh City centers and randomly assign them to two parallel arms. The experimental arm receives Vietnam MOH standard acupuncture points plus Five Shu points while the control arm receives MOH standard points alone, with needles retained for 30 minutes using a tonifying technique. Primary outcomes are sleep quality measured by the PSQI and Heart‑Spleen deficiency–specific TCM symptoms, assessed at 14 and 28 days. The design tests whether the addition of Five Shu points yields greater short‑term improvements in sleep and TCM symptom scores.

Who should consider this trial

Good fit: Adults aged 18 or older with DSM‑V chronic insomnia who meet TCM criteria for Heart‑Spleen deficiency, who have not used or have discontinued insomnia medications for at least two weeks, and who do not have other sleep disorders or severe psychiatric illness are the intended participants.

Not a fit: Patients with insomnia due to other causes, untreated other sleep disorders, ongoing psychotropic medication use, or who do not meet the TCM Heart‑Spleen deficiency pattern are unlikely to benefit from this specific intervention.

Why it matters

Potential benefit: If successful, adding Five Shu points could provide a non-drug option that improves sleep quality for patients with Heart‑Spleen deficiency insomnia.

How similar studies have performed: Acupuncture for insomnia has produced mixed results in prior research and high‑quality RCT evidence is limited, while Five Shu point–specific trials are scarce, so this particular approach remains relatively untested in rigorous trials.

Eligibility criteria

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.

Where this trial is running

Ho Chi Minh City and 2 other locations

• 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)

Study contacts

• Study coordinator: Nguyen Xuan Ngo, Doctor

Conditions: Insomnia, Nonorganic, Five-Shu acupoints, insomnia, acupuncture, Heart-Spleen deficiency