Intelligent Approach to Traditional Chinese Medicine for Insomnia

NCT ID: NCT06997289

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-28
• Study Completion Date: 2025-12-31

Brief Summary

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.

Detailed Description

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.

Conditions

Insomnia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Randomized controlled cross-over experimental design

Struggling to fall asleep or stay asleep, experiencing frequent awakenings, or finding it challenging to return to sleep after waking up.

Waking up early in the morning and being unable to go back to sleep. Sleep disturbances leading to significant distress or impairment in various aspects of life such as social, occupational, or academic functioning.

Experiencing difficulty sleeping on at least three nights a week for a period of at least three months.

No use of hypnotic or stable use of hypnotic and no medication adjustment in the past month

Group Type: EXPERIMENTAL

Group that is receiving treatment.

Intervention Type: 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

Interventions

Group that is receiving treatment.

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

Intervention Type: DRUG

Other Intervention Names

Auricular acupuncture

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

YEN Ying Kung

Role: CONTACT

yykung@vghtpe.gov.tw

0228757453

Other Identifiers

2024-10-005C

Identifier Type: -

Identifier Source: org_study_id