Insomnia, NonorganicNCT07544082
Acupuncture With Five Shu Points for Insomnia in Heart-Spleen Deficiency
A study testing Acupuncture at Viet Nam MOH standard points plus Five Shu points and Acupuncture at Viet Nam MOH standard points in people with Insomnia, Nonorganic, run by University of Medicine and Pharmacy at Ho Chi Minh City at 3 sites in Vietnam.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia, Nonorganic
- What is being tested?
- Acupuncture at Viet Nam MOH standard points plus Five Shu points and Acupuncture at Viet Nam MOH standard points
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 3 sitesVietnam
- Study dates
- 1 Mar 2026to 10 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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.
- 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.
- 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).
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- Co-existing mental disorders or medical conditions do not adequately explain the predominant complaint of insomnia.
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam3 sites, 3 recruiting
- Recruiting
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
Nguyen Xuan Ngo, Doctor, +84 946043639, nguyengo.nn@gmail.com
- Recruiting
Hospital 1A (1A Ly Thuong Kiet Street, Tan Son Nhat Ward, Ho Chi Minh City)
Ho Chi Minh City
Nguyen Xuan Ngo, Doctor, +84 946043639, nguyengo.nn@gmail.com
- Recruiting
University of Medicine and Pharmacy at Ho Chi Minh City
Ho Chi Minh City
About this study
Official title: 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.
Read the 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.
- Conditions
- Insomnia, Nonorganic
- Being tested
- Acupuncture at Viet Nam MOH standard points plus Five Shu points, Acupuncture at Viet Nam MOH standard points
- Keywords
- Five-Shu acupoints, insomnia, acupuncture, Heart-Spleen deficiency
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture at Viet Nam MOH standard points plus Five Shu pointsProcedure or surgery
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 at Viet Nam MOH standard pointsProcedure or surgery
Control arm: Same acupuncture at VIet Nam MOH standard points only, same schedule. All participants receive identical sleep hygiene psychoeducation as Intervention group
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Acupuncture at Viet Nam MOH standard points |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Every 14 days, 28 days post-intervention
Secondary outcomes (1)
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
Measured: From day 1 to day 28 of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start1 Mar 2026
- Primary completion1 Sep 2026 (estimated)
- Study completion10 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Insomnia, NonorganicStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ngo Xuan Nguyen, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07544082
- Sponsor's protocol ID
- 606/DHYD - HDDD
- Status last verified
- Mar 2026
- First submitted
- 9 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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 at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Five Shu Point Acupuncture in the Treatment of Insomnia in Patients With Heart-Spleen Deficiency Pattern: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07544082
- Acronym / sponsor ID
- 606/DHYD - HDDD
- Conditions
- Insomnia, Nonorganic
- Keywords
- Five-Shu acupoints, insomnia, acupuncture, Heart-Spleen deficiency
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 10 Sep 2026 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Acupuncture was administered at acupoints standardized by the Vietnam Ministry of Health | Experimental | Procedure: Acupuncture at Viet Nam MOH standard points plus Five Shu pointsParticipants 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. |
| Control group: Standard Acupuncture ( Vietnam MOH Protocol) | Active comparator | Procedure: Acupuncture at Viet Nam MOH standard pointsParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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:
- 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.
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture at Viet Nam MOH standard points plus Five Shu pointsExperimental 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. | Procedure or surgery | Acupuncture was administered at acupoints standardized by the Vietnam Ministry of Health |
| Acupuncture at Viet Nam MOH standard pointsControl arm: Same acupuncture at VIet Nam MOH standard points only, same schedule. All participants receive identical sleep hygiene psychoeducation as Intervention group | Procedure or surgery | Control group: Standard Acupuncture ( Vietnam MOH Protocol) |
Primary outcome
Insomnia Associated with Heart-Spleen Deficiency
Time frame: 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
Time frame: 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
1 secondary outcome
Adverse events related to acupuncture
Time frame: From day 1 to day 28 of intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- BackgroundZhang 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.
- BackgroundYuan CX. Clinical study of abdominal acupuncture for the treatment of insomnia of heart-spleen deficiency type [PhD thesis]. [Beijing]; 2020.
- BackgroundLiu 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.
- BackgroundShu 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.
- BackgroundWang W. Five-element acupuncture: a mind-body therapy originating from China. Science & Technology Review. 2019;37(15):91-97.
- BackgroundZhang 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.
- BackgroundLv 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture at Viet Nam MOH standard points plus Five Shu points and Acupuncture at Viet Nam MOH standard points in people with Insomnia, Nonorganic, run by University of Medicine and Pharmacy at Ho Chi Minh City at 3 sites in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nguyen Xuan Ngo, Doctor (+84 946043639, nguyengo.nn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Associated with Heart-Spleen Deficiency (time frame: every 14 days, 28 days post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07544082, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.