InsomniaNCT07735390
Chaihushugan Decoction and Wen Dan Tang for Insomnia
A study testing Chaihushugan Decoction and Wen Dan Tang in people with Insomnia and Sleep Wake Disorders, run by Tainan Hospital, Ministry of Health and Welfare at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Insomnia, Sleep Wake Disorders
- What is being tested?
- Chaihushugan Decoction and Wen Dan Tang
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Sep 2024to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Tainan Hospital, Ministry of Health and Welfare
Tainan
Yu-Ching Hsu, +886-6-2200055, tnhpcm2017@gmail.com
About this study
Official title: Effectiveness Evaluation of Chaihushugan Decoction and Wen Dan Tang Used in Treating Insomnia: A Pilot Randomized, Head-to-Head Trial
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.
Read the detailed description
This pilot randomized, parallel, head-to-head clinical trial is designed to investigate and compare the therapeutic effects of two classic Traditional Chinese Medicine (TCM) herbal formulas, Chaihushugan Decoction and Wen Dan Tang, for patients suffering from chronic insomnia.
Eligible patients recruited from the outpatient clinic of Tainan Hospital will be randomly allocated to one of the two intervention arms in a 1:1 ratio. Group A will receive Chaihushugan Decoction (2g, three times a day, oral administration), and Group B will receive Wen Dan Tang (2g, three times a day, oral administration). The total intervention period for both groups is 8 weeks.
To overcome the limitations of relying solely on subjective patient self-reports, this study implements a rigorous combination of objective and subjective assessment protocols. Objective sleep parameters-including sleep efficiency, total sleep time, sleep architecture, arousal index, and apnea-hypopnea index (AHI)-will be measured using overnight Digital Polysomnography (PSG) and actigraphy tracking. These evaluations will be conducted at three time points: baseline, week 4 (mid-treatment), and week 8 (post-treatment).
Simultaneously, standardized subjective clinical questionnaires will be administered to monitor psychological and sleep quality changes, including the Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), and the Hospital Anxiety and Depression Scale (HADS). The primary objective is to evaluate data-driven clinical responses and physiological alterations associated with these two distinct TCM patterns in sleep management.
- Conditions
- Insomnia, Sleep Wake Disorders
- Being tested
- Chaihushugan Decoction, Wen Dan Tang
- Keywords
- Chaihushugan Decoction
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chaihushugan DecoctionDrug
Traditional Chinese Medicine herbal formula granule. Dosage: 2 grams, three times a day, oral administration for 8 weeks.
Wen Dan TangDrug
Traditional Chinese Medicine herbal formula granule. Dosage: 2 grams, three times a day, oral administration for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Chaihushugan Decoction Group | Active comparator | Not described Receives: Drug: Chaihushugan Decoction |
| Wen Dan Tang Group | Active comparator | Not described Receives: Drug: Wen Dan Tang |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index (ISI) Score
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).
Measured: Baseline, Week 4, and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start13 Sep 2024
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tainan Hospital, Ministry of Health and Welfare
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Ching HSU, Tainan Hospital, Ministry of Health and Welfare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07735390
- Sponsor's protocol ID
- B-BR-112-014
- Status last verified
- Aug 2026
- First submitted
- 24 Jul 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Evaluation of Chaihushugan Decoction and Wen Dan Tang Used in Treating Insomnia: A Pilot Randomized, Head-to-Head Trial
- ClinicalTrials.gov ID
- NCT07735390
- Acronym / sponsor ID
- B-BR-112-014
- Conditions
- Insomnia, Sleep Wake Disorders
- Keywords
- Chaihushugan Decoction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Tainan Hospital, Ministry of Health and WelfareUniversity, hospital or other
- Study start
- 13 Sep 2024 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This pilot randomized, parallel, head-to-head clinical trial is designed to investigate and compare the therapeutic effects of two classic Traditional Chinese Medicine (TCM) herbal formulas, Chaihushugan Decoction and Wen Dan Tang, for patients suffering from chronic insomnia.
Eligible patients recruited from the outpatient clinic of Tainan Hospital will be randomly allocated to one of the two intervention arms in a 1:1 ratio. Group A will receive Chaihushugan Decoction (2g, three times a day, oral administration), and Group B will receive Wen Dan Tang (2g, three times a day, oral administration). The total intervention period for both groups is 8 weeks.
To overcome the limitations of relying solely on subjective patient self-reports, this study implements a rigorous combination of objective and subjective assessment protocols. Objective sleep parameters-including sleep efficiency, total sleep time, sleep architecture, arousal index, and apnea-hypopnea index (AHI)-will be measured using overnight Digital Polysomnography (PSG) and actigraphy tracking. These evaluations will be conducted at three time points: baseline, week 4 (mid-treatment), and week 8 (post-treatment).
Simultaneously, standardized subjective clinical questionnaires will be administered to monitor psychological and sleep quality changes, including the Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS), and the Hospital Anxiety and Depression Scale (HADS). The primary objective is to evaluate data-driven clinical responses and physiological alterations associated with these two distinct TCM patterns in sleep management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chaihushugan Decoction Group | Active comparator | Drug: Chaihushugan Decoction |
| Wen Dan Tang Group | Active comparator | Drug: Wen Dan Tang |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chaihushugan DecoctionTraditional Chinese Medicine herbal formula granule. Dosage: 2 grams, three times a day, oral administration for 8 weeks. | Drug | Chaihushugan Decoction Group |
| Wen Dan TangTraditional Chinese Medicine herbal formula granule. Dosage: 2 grams, three times a day, oral administration for 8 weeks. | Drug | Wen Dan Tang Group |
Primary outcome
Insomnia Severity Index (ISI) Score
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chaihushugan Decoction and Wen Dan Tang in people with Insomnia and Sleep Wake Disorders, run by Tainan Hospital, Ministry of Health and Welfare at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu-Ching Hsu (+886-6-2202121, tnhpcm2017@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (ISI) Score (time frame: Baseline, Week 4, and Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.