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Ancient herbal sleep aids put to the test with modern brain monitoring

NCT ID NCT07735390

Symptom relief Sponsor: Tainan Hospital, Ministry of Health and Welfare Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 30, 2026 · Last updated Aug 07, 2026 · Updated 2 times

Summary

This pilot trial compares two traditional Chinese herbal formulas — Chaihushugan Decoction and Wen Dan Tang — for treating chronic insomnia. Adults with chronic insomnia will take one of the two herbal granules three times daily for eight weeks. Unlike many herbal studies, this one uses objective sleep trackers like polysomnography alongside standard questionnaires to measure sleep quality. The goal is to see which formula may work better and to build scientific evidence for these ancient remedies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
two traditional Chinese herbal formulas: Chaihushugan Decoction and Wen Dan Tang
What this could lead to
If one formula proves more effective, it could offer a clearer, evidence-based herbal option for managing chronic insomnia.
What could go wrong
This is a very small pilot trial with only 24 participants, so results may not apply broadly. Herbal formulas can also cause side effects or interact with other medications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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).

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Conditions

The condition(s) this trial relates to.

insomnia sleep-wake disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Insomnia Sleep wake disorders

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Tainan Hospital, Ministry of Health and Welfare

    RECRUITING

    Tainan, Taiwan

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