Chaihushugan Decoction and Wen Dan Tang for Insomnia: A Pilot Randomized Controlled Trial

This pilot randomized, parallel, head-to-head clinical trial is designed to investigate and compare the therapeutic effects of two classic Traditional Chinese Medicine (TCM) herbal formulas, Chaihushugan Decoction and Wen Dan Tang, for patients suffering from chronic insomnia.

Eligible patients recruited from the outpatient clinic of Tainan Hospital will be randomly allocated to one of the two intervention arms in a 1:1 ratio. Group A will receive Chaihushugan Decoction (2g, three times a day, oral administration), and Group B will receive Wen Dan Tang (2g, three times a day, oral administration). The total intervention period for both groups is 8 weeks.

To overcome the limitations of relying solely on subjective patient self-reports, this study implements a rigorous combination of objective and subjective assessment protocols. Objective sleep parameters-including sleep efficiency, total sleep time, sleep architecture, arousal index, and apnea-hypopnea index (AHI)-will be measured using overnight Digital Polysomnography (PSG) and actigraphy tracking. These evaluations will be conducted at three time points: baseline, week 4 (mid-treatment), and week 8 (post-treatment).

Simultaneously, standardized subjective clinical questionnaires will be administered to monitor psychological and sleep quality changes, including the Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), and the Hospital Anxiety and Depression Scale (HADS). The primary objective is to evaluate data-driven clinical responses and physiological alterations associated with these two distinct TCM patterns in sleep management.

Inclusion criteria

• 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 criteria

• Diagnosed with schizophrenia or narcolepsy.
• History of neurological diseases (e.g., stroke history, neurodegenerative diseases).
• History of alcohol or drug addiction.
• Experiencing major, uncontrollable life-altering stressors (e.g., recent bereavement).