Intelligent Approach to Traditional Chinese Medicine for Insomnia

NCT06997289 | Not Yet Recruiting

• 1 other identifier: 2024-10-005C
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Insomnia

Keywords

auricular points,; Chinese medicine; pulse diagnosis

Outcome Measures

Primary Outcomes (1)

• Questionnaire evaluation

  Pittsburgh Sleep Quality Index, PSQI)

  up to 4 weeks"

Study Arms (1)

Randomized controlled cross-over experimental design

EXPERIMENTAL

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

Drug: Group that is receiving treatment.

Interventions

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

Also known as: Auricular acupuncture

Randomized controlled cross-over experimental design

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Acupuncture, Ear

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics; Auriculotherapy

Central Study Contacts

YEN Ying Kung

CONTACT

0228757453; yykung@vghtpe.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: May 30, 2025
• Study Start: May 28, 2025
• Primary Completion: December 19, 2025
• Study Completion: December 31, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-05