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

NCT07735390 | Recruiting

• 1 other identifier: B-BR-112-014
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Insomnia; Sleep Wake Disorders

Keywords

Chaihushugan Decoction

Outcome Measures

Primary Outcomes (1)

• Insomnia Severity Index (ISI) Score

  Baseline, Week 4, and Week 8

Study Arms (2)

Chaihushugan Decoction Group

ACTIVE COMPARATOR

Drug: Chaihushugan Decoction

Wen Dan Tang Group

ACTIVE COMPARATOR

Drug: Wen Dan Tang

Interventions

Chaihushugan Decoction DRUG

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

Chaihushugan Decoction Group

Wen Dan Tang DRUG

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

Wen Dan Tang Group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Tainan Hospital, Ministry of Health and Welfare: lead

Study Sites (1)

Tainan Hospital, Ministry of Health and Welfare

Tainan, Taiwan

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders

Interventions

kami-untan-to

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yu-Ching Hsu

CONTACT

+886-6-2202121; tnhpcm2017@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Sleep Center

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: July 30, 2026
• Study Start: September 13, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)