RecruitingNot ApplicableNCT07735390

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

Effectiveness Evaluation of Chaihushugan Decoction and Wen Dan Tang Used in Treating Insomnia: A Pilot Randomized, Head-to-Head Trial


Sponsor

Tainan Hospital, Ministry of Health and Welfare

Enrollment

24 participants

Start Date

Sep 13, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Chaihushugan Decoction and a drug called Wen Dan Tang for people with insomnia and sleep wake disorders. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGChaihushugan Decoction

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

DRUGWen 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

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NCT07735390


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