Myasthenia GravisNCT06754020
TCM Tongue Diagnosis and Syndrome Differentiation in Myasthenia Gravis Compared to Healthy Controls
A study testing Heart Rate Variability,HRV - ANSWatch and Traditional Chinese Medicine Tongue Imaging in people with Myasthenia Gravis, run by Yi Ting Yeh at 1 site in Taiwan.
Trial summary
Myasthenia gravis primarily results from neuromuscular junction dysfunction and damage, leading to chronic muscle weakness. While combined traditional and Western medicine treatments are now common, TCM tongue diagnosis remains a simple and practical clinical method. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myasthenia Gravis
- What is being tested?
- Heart Rate Variability,HRV - ANSWatch and Traditional Chinese Medicine Tongue Imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Jan 2023to 31 Dec 2027
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed with myasthenia gravis by a physician.
- Able to understand and communicate in Mandarin and Taiwanese.
- Cognitively alert and without a diagnosis of psychiatric disorders.
- Willing to undergo tongue imaging and instrument measurements.
Who cannot join
- Patients with severe organ diseases.
- Hearing loss patients who are unable to complete the questionnaire.
- Patients with aphasia who are unable to complete the questionnaire.
- Have eaten food or drinks that can easily contaminate tongue coating within 2 hours.
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
Yi Ting Yeh
New Taipei City, Tamsui District, 251
YI TING YEH, +886-952-166-103, ting79503@gmail.com
About this study
Official title: Application of Artificial Intelligence for Precision Medicine in TCM Tongue Diagnosis and Syndrome Differentiation in Myasthenia Gravis Compared to Healthy Controls
Myasthenia gravis primarily results from neuromuscular junction dysfunction and damage, leading to chronic muscle weakness. While combined traditional and Western medicine treatments are now common, TCM tongue diagnosis remains a simple and practical clinical method. However, results can vary among different practitioners. Therefore, you are interested in using scientific methods to compare TCM tongue diagnosis images between patients with myasthenia gravis and healthy individuals to aid in diagnosis.
Read the detailed description
In Taiwan, the prevalence of severe myasthenia gravis is approximately 14 per 100,000 people, with an incidence rate of about 2 per 100,000 people.
Currently, combined traditional and Western medicine treatments are very popular. In Traditional Chinese Medicine (TCM), tongue diagnosis is a simple and practical clinical method, focusing on aspects such as the tongue body, coating, color, and sublingual veins. Clinical evaluation often relies on the experience and knowledge of TCM practitioners, which can be influenced by subjective factors like diagnostic skills. As a result, findings may vary depending on the observer.
To improve diagnostic accuracy, using scientific methods to support TCM tongue diagnosis can provide more precise information for practitioners and enhance the clinical application value of tongue diagnosis in TCM.
- Conditions
- Myasthenia Gravis
- Being tested
- Heart Rate Variability,HRV - ANSWatch, Traditional Chinese Medicine Tongue Imaging
- Keywords
- Myasthenia Gravis, traditional Chinese medicine
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart Rate Variability,HRV - ANSWatchDevice
Please have the participant lie down and rest for 10 minutes, and remove any metallic items from their body. Next, put on the wrist-worn monitor, and avoid moving during the monitoring process. The device will emit a sound when the monitoring session is complete.
Traditional Chinese Medicine Tongue ImagingDevice
Use a camera to capture images of the tongue, and then have a Traditional Chinese Medicine (TCM) practitioner perform the diagnosis based on these images.
| Study group | Role | What they receive |
|---|---|---|
| Disease Group | Experimental | Participants with myasthenia gravis will be recruited and assessed in the Neurology Department's outpatient clinic and wards at Shin Kong Hospital. Receives: Device: Heart Rate Variability,HRV - ANSWatch; Device: Traditional Chinese Medicine Tongue Imaging |
| **Healthy Control Group** | Experimental | The healthy control group will be recruited from community settings and universities in Taipei City. Receives: Device: Heart Rate Variability,HRV - ANSWatch; Device: Traditional Chinese Medicine Tongue Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
What are the differences in tongue diagnosis in traditional Chinese medicine between the disease group and the healthy population?
Using a camera to capture images of the tongue, traditional Chinese medicine practitioners were invited to evaluate the tongue photographs. After organizing the data, a comparison between the two groups was conducted in the fourth week.
Measured: 2025/01/18 (4th week)
Secondary outcomes (1)
Observe the differences in physical constitution and tongue diagnosis between patients with myasthenia and healthy people.
The disease group and the control group were asked to complete the Traditional Chinese Medicine Constitution Questionnaire (TCMCQ) separately. After organizing the data, statistical analysis was conducted in the fourth week.
Measured: 2025/01/18 (4th week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start17 Jan 2023
- Primary completion17 Jan 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myasthenia GravisStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yi Ting Yeh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yi Ting Yeh, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06754020
- Sponsor's protocol ID
- 20221019R
- Status last verified
- Apr 2026
- First submitted
- 8 Aug 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Artificial Intelligence for Precision Medicine in TCM Tongue Diagnosis and Syndrome Differentiation in Myasthenia Gravis Compared to Healthy Controls
- ClinicalTrials.gov ID
- NCT06754020
- Acronym / sponsor ID
- 20221019R
- Conditions
- Myasthenia Gravis
- Keywords
- Myasthenia Gravis, traditional Chinese medicine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yi Ting YehUniversity, hospital or other
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 17 Jan 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 31 Dec 2024 (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.
Myasthenia gravis primarily results from neuromuscular junction dysfunction and damage, leading to chronic muscle weakness. While combined traditional and Western medicine treatments are now common, TCM tongue diagnosis remains a simple and practical clinical method. However, results can vary among different practitioners. Therefore, you are interested in using scientific methods to compare TCM tongue diagnosis images between patients with myasthenia gravis and healthy individuals to aid in diagnosis.
Detailed description
In Taiwan, the prevalence of severe myasthenia gravis is approximately 14 per 100,000 people, with an incidence rate of about 2 per 100,000 people.
Currently, combined traditional and Western medicine treatments are very popular. In Traditional Chinese Medicine (TCM), tongue diagnosis is a simple and practical clinical method, focusing on aspects such as the tongue body, coating, color, and sublingual veins. Clinical evaluation often relies on the experience and knowledge of TCM practitioners, which can be influenced by subjective factors like diagnostic skills. As a result, findings may vary depending on the observer.
To improve diagnostic accuracy, using scientific methods to support TCM tongue diagnosis can provide more precise information for practitioners and enhance the clinical application value of tongue diagnosis in TCM.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Disease Group | Experimental | Device: Heart Rate Variability,HRV - ANSWatch, Device: Traditional Chinese Medicine Tongue ImagingParticipants with myasthenia gravis will be recruited and assessed in the Neurology Department's outpatient clinic and wards at Shin Kong Hospital. |
| **Healthy Control Group** | Experimental | Device: Heart Rate Variability,HRV - ANSWatch, Device: Traditional Chinese Medicine Tongue ImagingThe healthy control group will be recruited from community settings and universities in Taipei City. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with myasthenia gravis by a physician.
- Able to understand and communicate in Mandarin and Taiwanese.
- Cognitively alert and without a diagnosis of psychiatric disorders.
- Willing to undergo tongue imaging and instrument measurements.
Key exclusion criteria (4 listed)
- Patients with severe organ diseases.
- Hearing loss patients who are unable to complete the questionnaire.
- Patients with aphasia who are unable to complete the questionnaire.
- Have eaten food or drinks that can easily contaminate tongue coating within 2 hours.
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 |
|---|---|---|
| Heart Rate Variability,HRV - ANSWatchPlease have the participant lie down and rest for 10 minutes, and remove any metallic items from their body. Next, put on the wrist-worn monitor, and avoid moving during the monitoring process. The device will emit a sound when the monitoring session is complete. | Device | **Healthy Control Group**, Disease Group |
| Traditional Chinese Medicine Tongue ImagingUse a camera to capture images of the tongue, and then have a Traditional Chinese Medicine (TCM) practitioner perform the diagnosis based on these images. | Device | **Healthy Control Group**, Disease Group |
Primary outcome
What are the differences in tongue diagnosis in traditional Chinese medicine between the disease group and the healthy population?
Time frame: 2025/01/18 (4th week)
Using a camera to capture images of the tongue, traditional Chinese medicine practitioners were invited to evaluate the tongue photographs. After organizing the data, a comparison between the two groups was conducted in the fourth week.
1 secondary outcome
Observe the differences in physical constitution and tongue diagnosis between patients with myasthenia and healthy people.
Time frame: 2025/01/18 (4th week)
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 13 Apr 2026.
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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 Heart Rate Variability,HRV - ANSWatch and Traditional Chinese Medicine Tongue Imaging in people with Myasthenia Gravis, run by Yi Ting Yeh 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 13 Apr 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 YI TIMG YEH (+866-952-166-103, reinating90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
What are the differences in tongue diagnosis in traditional Chinese medicine between the disease group and the healthy population? (time frame: 2025/01/18 (4th week)). 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 13 Apr 2026.