Efficacy of Five Shu Point Acupuncture in the Treatment of Insomnia in Patients With Heart-Spleen Deficiency Pattern: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 46
- 试验地点
- 3
- 主要终点
- Insomnia Associated with Heart-Spleen Deficiency
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Acupuncture at Viet Nam MOH standard points plus Five Shu points (Procedure)
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.
干预措施: Acupuncture at Viet Nam MOH standard points (Procedure)
结局指标
主要结局
Insomnia Associated with Heart-Spleen Deficiency
时间窗: every 14 days, 28 days post-intervention
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
Insomnia Associated with Heart-Spleen Deficiency
时间窗: Every 14 days, 28 days post-intervention
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
次要结局
- Adverse events related to acupuncture(From day 1 to day 28 of intervention)
研究者
Ngo Xuan Nguyen
Doctor
University of Medicine and Pharmacy at Ho Chi Minh City