Chaihushugan Decoction and Wen Dan Tang for Insomnia
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Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Tainan Hospital, Ministry of Health and Welfare
- Trial code
- NCT07735390
- Record updated
- 7 August 2026
- Original description
This study aims to evaluate the clinical effectiveness of Traditional Chinese Medicine (TCM) in treating sleep disorders, specifically chronic insomnia. While conventional TCM treatments often rely heavily on subjective patient feedback, this clinical trial incorporates objective diagnostic tools, including Digital Polysomnography (PSG) and actigraphy, to gather data-driven sleep quality metrics.Read full original descriptionShow less
Effectiveness Evaluation of Chaihushugan Decoction and Wen Dan Tang Used in Treating Insomnia: A Pilot Randomized, Head-to-Head Trial
This study aims to evaluate the clinical effectiveness of Traditional Chinese Medicine (TCM) in treating sleep disorders, specifically chronic insomnia. While conventional TCM treatments often rely heavily on subjective patient feedback, this clinical trial incorporates objective diagnostic tools, including Digital Polysomnography (PSG) and actigraphy, to gather data-driven sleep quality metrics.
Participants will be randomly assigned to receive either Chaihushugan Decoction or Wen Dan Tang for an 8-week treatment period. Subjective improvements will be tracked using standardized clinical questionnaires such as the Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI). The findings from this trial will help clarify the scientific basis and treatment pathways of these two classic herbal formulations for sleep management.
Inclusion: Patients aged 20 or older seeking treatment at the Traditional Chinese Medicine outpatient clinic with sleep disorders; Meet the diagnostic criteria for chronic insomnia according to the International Classification of Sleep Disorders, Third Edition (ICSD-3); Willing to receive traditional Chinese medicine treatment; Able to provide signed informed consent approved by the National Cheng Kung University Hospital Institutional Review Board.
Exclusion: History of neurological diseases (e.g., stroke history, neurodegenerative diseases); History of alcohol or drug addiction; Diagnosed with schizophrenia or narcolepsy; Experiencing major, uncontrollable life-altering stressors (e.g., recent bereavement).