Chaihushugan Decoction and Wen Dan Tang for Insomnia

Condition(s) studied

Investigational drug(s) / intervention(s)

Chaihushugan Decoction: Traditional Chinese Medicine herbal formula granule. Dosage: 2 grams, three times a day, oral administration for 8 weeks.

Wen Dan Tang: Traditional Chinese Medicine herbal formula granule. Dosage: 2 grams, three times a day, oral administration for 8 weeks.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Insomnia Severity Index (ISI) Score — Baseline, Week 4, and Week 8
  Evaluated using the Insomnia Severity Index (ISI), a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia. Each item is rated on a a 0-4 scale, yielding a total score ranging from 0 to 28. Higher scores indicate a worse outcome (greater severity of insomnia symptoms).

Trial sites (1)

More Tainan Hospital, Ministry of Health and Welfare trials in Taiwan

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