drugset / Trial / NCT06997289

Intelligent Approach to Traditional Chinese Medicine for Insomnia

NCT06997289

Not yet recruiting 120 enrolled Taipei Veterans General Hospital, Taiwan
NaSingle-groupOpen-labelTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Fushen Traditional medicine (herbal / TCM) 0.5 g Oral
Subject Modified Xiaoyao Powder Traditional medicine (herbal / TCM) 2 g Oral
Subject Night Jiaoteng Traditional medicine (herbal / TCM) 0.5 g Oral
Subject Tianwang Buxin Dan Traditional medicine (herbal / TCM) 1.5 g Oral
Subject Wendan Decoction Traditional medicine (herbal / TCM) 0.5 g Oral

Indications