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

Recruiting now · Not applicable

Conditions studied: Insomnia, Nonorganic

In brief

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.

Key facts

Study ID

NCT07544082

Run by

University of Medicine and Pharmacy at Ho Chi Minh City

People needed

46

Starts

2026-03-01

Expected to finish

2026-09-10

Last updated by the study team

2026-04-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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.

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.

Where it is running

• 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 (enrolling)
• Hospital 1A (1A Ly Thuong Kiet Street, Tan Son Nhat Ward, Ho Chi Minh City) — Ho Chi Minh City, Vietnam (enrolling)
• University of Medicine and Pharmacy at Ho Chi Minh City — Ho Chi Minh City, Vietnam (enrolling)

Full record on ClinicalTrials.gov

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