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Intelligent Approach to Traditional Chinese Medicine for Insomnia

NCT06997289 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-05-30

No results posted yet for this study

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

Interventions

DRUG

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

Sponsors & Collaborators

  • Taipei Veterans General Hospital, Taiwan

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-28
Primary Completion
2025-12-19
Completion
2025-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06997289 on ClinicalTrials.gov