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RECRUITING
NCT07735390
NA

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

Sponsor: Tainan Hospital, Ministry of Health and Welfare

View on ClinicalTrials.gov

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

Interventions

DRUG

Chaihushugan Decoction

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

DRUG

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