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NOT YET RECRUITING
NCT06997289
NA

Intelligent Approach to Traditional Chinese Medicine for Insomnia

Sponsor: Taipei Veterans General Hospital, Taiwan

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

20 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2025-05-28

Completion Date

2025-12-31

Last Updated

2025-05-30

Healthy Volunteers

No

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