Health TrialsbyHealthPanel

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

ConditionInsomnia, Nonorganic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Medicine and Pharmacy at Ho Chi Minh City

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 who are able to understand Vietnamese.

Sleeplessness throughout the night, or light sleep with frequent awakening; fragmented sleep.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Procedure/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 points

    Procedure/Surgery

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

Treatment groups

46 Participants
are divided into 2 treatment groups
Group A: Acupuncture was administered at acupoints standardized by the Vietnam Ministry of HealthExperimental treatment 1 intervention
Group B: Control group: Standard Acupuncture ( Vietnam MOH Protocol)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
every 14 days, 28 days post-intervention
2

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

Time frame
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

Time frame
From day 1 to day 28 of intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Medicine and Pharmacy at Ho Chi Minh City

Lead sponsor

Source ClinicalTrials.gov
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