Intelligent Approach to Traditional Chinese Medicine for Insomnia

Insomnia is a very common health issue, affecting over 40% of the population in Chinese-speaking regions. The impact of insomnia on society, economy, mental health, and physical health is significant, with previous research indicating that insomnia is associated with an increased risk of high blood pressure, heart disease, anxiety, and depression, which can ultimately lead to a decline in quality of life. Treatment for insomnia includes non-pharmacological and pharmacological interventions, with clinical practice often utilizing sedative medications for sleep, but with side effects such as dependency, tolerance, daytime drowsiness, and withdrawal symptoms, which make it challenging for patients to find suitable medical treatment. Traditional Chinese Medicine (TCM) approaches insomnia by first conducting a thorough assessment based on individualized patterns (differentiation of body constitution) and evaluating insomnia-related symptoms, followed by an examination of tongue and pulse to determine the correct treatment plan, which may involve acupuncture, herbal medicine or a combination of both (integrative treatment). Due to the complex nature of insomnia, a definitive diagnosis requires neuroimaging and other measures during sleep studies to assess brain wave activity, if possible, to understand the cognitive impact.

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

In the treatment of insomnia, Chinese medicine first assesses the individual's constitution and symptoms related to insomnia, before incorporating auricular acupuncture and pulse diagnosis. Subsequently, different syndrome types are identified and treated with acupuncture or traditional Chinese medicine (dialectical treatment). Since insomnia is often subjective, a definitive diagnosis may require overnight monitoring of brain waves and other parameters in a sleep laboratory. Smart imaging methods can help detect special reaction areas of ear points, while pulse diagnosis equipment can provide objective auxiliary diagnosis and classification of insomnia through pulse wave digital conversion analysis. Previous studies have demonstrated the effectiveness of auricular point stimulation in treating insomnia, and this study aims to enhance the therapeutic outcomes for primary insomnia by combining Chinese medicine techniques.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Major mental illnesses include schizophrenia, bipolar disorder, major depression, dementia, apnea, restless legs syndrome, alcohol and substance abuse, organic psychosis and those with major physiological illnesses that affect sleep.

Exclusion criteria

As per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) published by the American Psychiatric Association, insomnia is characterized.

Treatment and study plan

Group that is receiving treatment.

Drug

Incorporate the following regimen into your daily routine for optimal health benefits:

Chinese Medicine: Take a combination of Modified Xiaoyao Powder (2g), Tianwang Buxin Dan (1.5g), Wendan Decoction (0.5g), Night Jiaoteng (0.5g), and Fushen (0.5g) twice a day for a duration of 1 month. This regimen comes from Keda GMP Pharmaceutical Factory.

Auricular Point Stimulation: Apply small 0.2cm ear magnetic beads on the Shenmen, heart, and brainstem points on both sides of the ear.

Consistency is key to achieving positive results, so make sure to follow this routine diligently.

Two treatment methods are carried out simultaneously

Other names: Auricular acupuncture

Primary outcomes

Questionnaire evaluation

Time frame: up to 4 weeks"

Pittsburgh Sleep Quality Index, PSQI)

Study contacts

Contact information is provided by the study sponsor or research team.

YEN Ying Kung

CONTACT

[email protected]

0228757453

Sponsors and collaborators

Lead sponsor

Taipei Veterans General Hospital, Taiwan

Other Gov

Registry information

Official study title

Intelligent Complementary Diagnosis and Treatment of Traditional Chinese Medicine for Primary Insomnia

Acronym: TCM

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: May 30, 2025
Registry last updated: May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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