InsomniaTCMNCT06997289
Intelligent Approach to Traditional Chinese Medicine for Insomnia
A study testing Group that is receiving treatment. in people with Insomnia, run by Taipei Veterans General Hospital, Taiwan.
Trial summary
Insomnia is a very common health issue, affecting over 40% of the population in Chinese-speaking regions. The impact of insomnia on society, economy, mental health, and physical health is significant, with previous research indicating that insomnia is associated with an increased risk of high blood pressure, heart… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Insomnia
- What is being tested?
- Group that is receiving treatment.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 28 May 2025to 31 Dec 2025
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Major mental illnesses include schizophrenia, bipolar disorder, major depression, dementia, apnea, restless legs syndrome, alcohol and substance abuse, organic psychosis and those with major physiological illnesses that affect sleep.
Who cannot join
- As per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) published by the American Psychiatric Association, insomnia is characterized.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Intelligent Complementary Diagnosis and Treatment of Traditional Chinese Medicine for Primary Insomnia
Insomnia is a very common health issue, affecting over 40% of the population in Chinese-speaking regions. The impact of insomnia on society, economy, mental health, and physical health is significant, with previous research indicating that insomnia is associated with an increased risk of high blood pressure, heart disease, anxiety, and depression, which can ultimately lead to a decline in quality of life. Treatment for insomnia includes non-pharmacological and pharmacological interventions, with clinical practice often utilizing sedative medications for sleep, but with side effects such as dependency, tolerance, daytime drowsiness, and withdrawal symptoms, which make it challenging for patients to find suitable medical treatment. Traditional Chinese Medicine (TCM) approaches insomnia by first conducting a thorough assessment based on individualized patterns (differentiation of body constitution) and evaluating insomnia-related symptoms, followed by an examination of tongue and pulse to determine the correct treatment plan, which may involve acupuncture, herbal medicine or a combination of both (integrative treatment). Due to the complex nature of insomnia, a definitive diagnosis requires neuroimaging and other measures during sleep studies to assess brain wave activity, if possible, to understand the cognitive impact.
Read the detailed description
In the treatment of insomnia, Chinese medicine first assesses the individual's constitution and symptoms related to insomnia, before incorporating auricular acupuncture and pulse diagnosis. Subsequently, different syndrome types are identified and treated with acupuncture or traditional Chinese medicine (dialectical treatment). Since insomnia is often subjective, a definitive diagnosis may require overnight monitoring of brain waves and other parameters in a sleep laboratory. Smart imaging methods can help detect special reaction areas of ear points, while pulse diagnosis equipment can provide objective auxiliary diagnosis and classification of insomnia through pulse wave digital conversion analysis. Previous studies have demonstrated the effectiveness of auricular point stimulation in treating insomnia, and this study aims to enhance the therapeutic outcomes for primary insomnia by combining Chinese medicine techniques.
- Conditions
- Insomnia
- Being tested
- Group that is receiving treatment.
- Keywords
- auricular points,, Chinese medicine, pulse diagnosis
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group that is receiving treatment.Drug
Also called Auricular acupuncture
Incorporate the following regimen into your daily routine for optimal health benefits:
Chinese Medicine: Take a combination of Modified Xiaoyao Powder (2g), Tianwang Buxin Dan (1.5g), Wendan Decoction (0.5g), Night Jiaoteng (0.5g), and Fushen (0.5g) twice a day for a duration of 1 month. This regimen comes from Keda GMP Pharmaceutical Factory.
Auricular Point Stimulation: Apply small 0.2cm ear magnetic beads on the Shenmen, heart, and brainstem points on both sides of the ear.
Consistency is key to achieving positive results, so make sure to follow this routine diligently.
Two treatment methods are carried out simultaneously
| Study group | Role | What they receive |
|---|---|---|
| Randomized controlled cross-over experimental design | Experimental | Struggling to fall asleep or stay asleep, experiencing frequent awakenings, or finding it challenging to return to sleep after waking up.
Waking up early in the morning and being unable to go back to sleep. Sleep disturbances leading to significant distress or impairment in various aspects of life such as social, occupational, or academic functioning.
Experiencing difficulty sleeping on at least three nights a week for a period of at least three months.
No use of hypnotic or stable use of hypnotic and no medication adjustment in the past month Receives: Drug: Group that is receiving treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire evaluation
Pittsburgh Sleep Quality Index, PSQI)
Measured: up to 4 weeks"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start28 May 2025 (estimated)
- Primary completion19 Dec 2025 (estimated)
- Study completion31 Dec 2025 (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.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06997289
- Sponsor's protocol ID
- 2024-10-005C
- Acronym
- TCM
- Status last verified
- May 2025
- First submitted
- 10 Feb 2025
- Last updated
- 30 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intelligent Complementary Diagnosis and Treatment of Traditional Chinese Medicine for Primary Insomnia
- ClinicalTrials.gov ID
- NCT06997289
- Acronym / sponsor ID
- TCM / 2024-10-005C
- Conditions
- Insomnia
- Keywords
- auricular points,, Chinese medicine, pulse diagnosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 28 May 2025 (estimated)
- Primary completion
- 19 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 30 May 2025 (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.
Insomnia is a very common health issue, affecting over 40% of the population in Chinese-speaking regions. The impact of insomnia on society, economy, mental health, and physical health is significant, with previous research indicating that insomnia is associated with an increased risk of high blood pressure, heart disease, anxiety, and depression, which can ultimately lead to a decline in quality of life. Treatment for insomnia includes non-pharmacological and pharmacological interventions, with clinical practice often utilizing sedative medications for sleep, but with side effects such as dependency, tolerance, daytime drowsiness, and withdrawal symptoms, which make it challenging for patients to find suitable medical treatment. Traditional Chinese Medicine (TCM) approaches insomnia by first conducting a thorough assessment based on individualized patterns (differentiation of body constitution) and evaluating insomnia-related symptoms, followed by an examination of tongue and pulse to determine the correct treatment plan, which may involve acupuncture, herbal medicine or a combination of both (integrative treatment). Due to the complex nature of insomnia, a definitive diagnosis requires neuroimaging and other measures during sleep studies to assess brain wave activity, if possible, to understand the cognitive impact.
Detailed description
In the treatment of insomnia, Chinese medicine first assesses the individual's constitution and symptoms related to insomnia, before incorporating auricular acupuncture and pulse diagnosis. Subsequently, different syndrome types are identified and treated with acupuncture or traditional Chinese medicine (dialectical treatment). Since insomnia is often subjective, a definitive diagnosis may require overnight monitoring of brain waves and other parameters in a sleep laboratory. Smart imaging methods can help detect special reaction areas of ear points, while pulse diagnosis equipment can provide objective auxiliary diagnosis and classification of insomnia through pulse wave digital conversion analysis. Previous studies have demonstrated the effectiveness of auricular point stimulation in treating insomnia, and this study aims to enhance the therapeutic outcomes for primary insomnia by combining Chinese medicine techniques.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Randomized controlled cross-over experimental design | Experimental | Drug: Group that is receiving treatment.Struggling to fall asleep or stay asleep, experiencing frequent awakenings, or finding it challenging to return to sleep after waking up. Waking up early in the morning and being unable to go back to sleep. Sleep disturbances leading to significant distress or impairment in various aspects of life such as social, occupational, or academic functioning. Experiencing difficulty sleeping on at least three nights a week for a period of at least three months. No use of hypnotic or stable use of hypnotic and no medication adjustment in the past month |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Major mental illnesses include schizophrenia, bipolar disorder, major depression, dementia, apnea, restless legs syndrome, alcohol and substance abuse, organic psychosis and those with major physiological illnesses that affect sleep.
Key exclusion criteria (1 listed)
- As per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) published by the American Psychiatric Association, insomnia is characterized.
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 |
|---|---|---|
| Group that is receiving treatment.Also: Auricular acupunctureIncorporate the following regimen into your daily routine for optimal health benefits: Chinese Medicine: Take a combination of Modified Xiaoyao Powder (2g), Tianwang Buxin Dan (1.5g), Wendan Decoction (0.5g), Night Jiaoteng (0.5g), and Fushen (0.5g) twice a day for a duration of 1 month. This regimen comes from Keda GMP Pharmaceutical Factory. Auricular Point Stimulation: Apply small 0.2cm ear magnetic beads on the Shenmen, heart, and brainstem points on both sides of the ear. Consistency is key to achieving positive results, so make sure to follow this routine diligently. Two treatment methods are carried out simultaneously | Drug | Randomized controlled cross-over experimental design |
Primary outcome
Questionnaire evaluation
Time frame: up to 4 weeks"
Pittsburgh Sleep Quality Index, PSQI)
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 30 May 2025.
Related trials for Insomnia
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
RecruitingPhase 3
A Trial to See if Daridorexant Can Help Adults and Elderly People With Insomnia Sleep Better During the Night and Function Better During the Day
Insomia Disorder
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.
Questions about this trial
What is this clinical trial studying?
A study testing Group that is receiving treatment. in people with Insomnia, run by Taipei Veterans General Hospital, 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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 YEN Ying Kung (0228757453, yykung@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire evaluation (time frame: up to 4 weeks"). 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 30 May 2025.