Chaihushugan Decoction vs Wen Dan Tang for Chronic Insomnia
Official title: Effectiveness Evaluation of Chaihushugan Decoction and Wen Dan Tang Used in Treating Insomnia: A Pilot Randomized, Head-to-Head Trial
Run by Tainan Hospital, Ministry of Health and Welfare · NCT07735390 · Data updated 2026-11-12
This trial tests two traditional Chinese medicine formulas to see if one helps adults with chronic insomnia more than the other over 8 weeks.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 20 Years and up |
| Sex | All |
| Enrollment | 24 (estimated) |
| Sponsor | Tainan Hospital, Ministry of Health and Welfare Academic / other |
| Locations | 1 site (Tainan) |
| Status | Recruiting |
| Started | September 13, 2024 |
| Main results expected | December 31, 2029 |
| Study ends | December 31, 2029 |
| Registry record updated | August 7, 2026 |
| Trial ID | NCT07735390 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with chronic insomnia who are seeking traditional Chinese medicine and able to consent at Tainan Hospital.
✕Probably not a fit
Individuals with narcolepsy, schizophrenia, significant neurological disease, active substance use, or severe life stressors may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a head-to-head, randomized pilot trial comparing Chaihushugan Decoction and Wen Dan Tang in adults with chronic insomnia. Objective sleep metrics will be collected with overnight polysomnography and actigraphy at baseline, week 4, and week 8, alongside subjective questionnaires such as ISI, PSQI, ESS, and HADS. The study aims to clarify whether these classic herbal formulas produce measurable sleep improvements beyond patient-reported outcomes. Participants are adults 20 years and older treated at Tainan Hospital, randomly assigned 1:1 to either formula for 8 weeks. Outcomes include both sleep parameters and quality-of-life measures to understand potential treatment pathways in TCM for sleep disorders.
Why it matters
Potential benefit: If successful, participants and others with chronic insomnia could gain a data-backed option from traditional herbal medicines.
How similar studies have gone: Previous studies of similar TCM formulas for sleep have shown mixed results; this head-to-head design seeks clearer comparative data.
Who can join: the full rules
Show full inclusion / exclusion criteria
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).
Where it's running
-
Tainan Hospital, Ministry of Health and Welfare
Tainan, Taiwan Recruiting
Study contacts
- Study coordinator: Yu-Ching Hsu
- Email: tnhpcm2017@gmail.com
- Phone: +886-6-2202121
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.