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Chaihushugan Decoction and Wen Dan Tang for Insomnia: A Pilot Randomized Controlled Trial
Sponsor: Tainan Hospital, Ministry of Health and Welfare
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.
Official title: Effectiveness Evaluation of Chaihushugan Decoction and Wen Dan Tang Used in Treating Insomnia: A Pilot Randomized, Head-to-Head Trial
Key Details
Gender
All
Age Range
20 Years - Any
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2024-09-13
Completion Date
2029-12-31
Last Updated
2026-07-30
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
Tainan Hospital, Ministry of Health and Welfare
Tainan, Taiwan