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Evaluation of the Efficacy of Thread Embedding Acupuncture Combined With Auricular Acupressure Based on Traditional Chinese Medicine Clinical Syndromes in Patients With Non-Organic Insomnia

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Non-organic insomnia is a prevalent disorder that significantly impairs quality of life, characterized by difficulty initiating or maintaining sleep alongside daytime functional decline. This condition is particularly common among adults facing chronic stress, which increases the risk of chronic diseases and dysregulates the Microbiota-Gut-Brain Axis (MGBA)-a bidirectional communication system between the central nervous system and the gut microbiota. Prolonged sleep deprivation and stress can trigger inflammatory responses and gut dysbiosis, which in turn exacerbate emotional and sleep disturbances. While conventional sedative-hypnotics often carry side effects and risks of dependency, traditional medicine interventions are emerging as potential sustainable solutions. This study evaluates the efficacy of thread embedding combined with auricular acupressure based on individualized traditional Chinese medicine syndrome differentiation, while clarifying the relationship between clinical sleep improvement and changes in MGBA-related inflammatory markers, specifically interleukin-6 and calprotectin. The goal of this clinical trial is to evaluate the clinical efficacy and preliminarily investigate the mechanisms of action-via the Microbiota-Gut-Brain Axis-of individualized Traditional Chinese Medicine (targeting Heart-Spleen Deficiency and Liver Qi Stagnation syndromes) using thread embedding acupuncture combined with auricular acupressure to improve sleep quality in patients with insomnia, compared to a non-individualized protocol. The main questions it aims to answer are: * Does the combined method of thread embedding acupuncture and auricular acupressure based on syndrome differentiation improve sleep quality more effectively than the standardized protocol? * Is there a significant difference in the change of IL-6 and Calprotectin levels following treatment in the intervention group compared to the control group? * Does post-treatment clinical improvement correlate with the reduction of these inflammatory markers? Participants will: * Receive thread embedding acupuncture sessions every 4 weeks and have ear seeds (auricular acupressure) replaced every 2 weeks . Self-massage the ear seeds for 1 to 2 minutes several times each day, especially before bedtime. * Complete assessments of sleep quality (PSQI, ISI) and digestive health (GSRS) every 2 weeks through week 8. * Provide blood and stool samples at the start and end of the study to measure inflammation markers. * Be monitored for any adverse effects, such as local pain, dizziness, or needle fainting, during the trial period.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 75
Healthy Volunteers: f
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• Age: 40 to 75 years.

• Cognitive Function: Mini-Mental State Examination (MMSE) score \> 24.

• Stable Comorbidities: Participants with hypertension or diabetes must be well-controlled with medication (Blood Pressure \< 140/90 mmHg, HbA1c \< 7%) and have no changes in their medication regimen within the last 3 months.

• Modern Medical Criteria: Diagnosis of Chronic Insomnia Disorder according to the International Classification of Sleep Disorders, 3rd Edition (ICSD-3).

• Sleep Quality Scores: A Pittsburgh Sleep Quality Index (PSQI) score \>= 5 and a total Insomnia Severity Index (ISI) score \>= 10.

• TCM Syndrome: Diagnosed with one of the following Traditional Chinese Medicine syndromes: Heart-Spleen Deficiency, Liver Qi Stagnation, or Liver Qi Stagnation with Spleen Deficiency.

• Informed Consent: Participants must voluntarily sign the informed consent form and agree to comply with study requirements, including stool sample collection.

Locations
Other Locations
Viet Nam
Thong Nhat Hospital
RECRUITING
Ho Chi Minh City
Contact Information
Primary
Huong TL Le, MD, MSc
lanhuong@ump.edu.vn
+84-983506700
Time Frame
Start Date: 2026-05-18
Estimated Completion Date: 2027-12
Participants
Target number of participants: 70
Treatments
Active_comparator: Standardized Protocol
Thread embedding acupuncture performed twice at a 4-week interval using absorbable sutures placed at a fixed set of points for all participants .~Auricular acupressure using Vaccaria seeds is applied and replaced every 2 weeks throughout the 8-week study. Participants are instructed to perform self-massage on the ear seeds 3-5 times daily for 1-2 minutes per point, particularly 30 minutes before bedtime.
Experimental: Individualized TCM
Individualized Traditional Chinese Medicine (TCM) syndrome-based therapy tailored to either Heart-Spleen Deficiency or Liver Qi Stagnation:~* Thread embedding acupuncture is performed twice at a 4-week interval using absorbable sutures placed at points tailored to the participant's specific syndrome.~* Auricular acupressure using Vaccaria seeds is applied to ear points tailored to the diagnosis and replaced every 2 weeks throughout the 8-week study. Participants are instructed to perform self-massage on the ear seeds 3-5 times daily for 1-2 minutes per point, particularly 30 minutes before bedtime .
Related Therapeutic Areas
Sponsors
Leads: University of Medicine and Pharmacy at Ho Chi Minh City

This content was sourced from clinicaltrials.gov