TCM Tongue Diagnosis and Syndrome Differentiation in Myasthenia Gravis Compared to Healthy Controls

April 7, 2026 updated by: Yi Ting Yeh

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
    • Tamsui District
      • New Taipei City, Tamsui District, Taiwan, 251
        • Recruiting
        • Yi Ting Yeh
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Diagnosed with myasthenia gravis by a physician.
  2. Able to understand and communicate in Mandarin and Taiwanese.
  3. Cognitively alert and without a diagnosis of psychiatric disorders.
  4. Willing to undergo tongue imaging and instrument measurements.

Exclusion Criteria:

  1. Patients with severe organ diseases.
  2. Hearing loss patients who are unable to complete the questionnaire.
  3. Patients with aphasia who are unable to complete the questionnaire.
  4. Have eaten food or drinks that can easily contaminate tongue coating within 2 hours.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Disease Group
Participants with myasthenia gravis will be recruited and assessed in the Neurology Department's outpatient clinic and wards at Shin Kong Hospital.
Device: Heart Rate Variability,HRV - ANSWatch
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.
Device: Traditional Chinese Medicine Tongue Imaging
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.
Experimental: **Healthy Control Group**
The healthy control group will be recruited from community settings and universities in Taipei City.
Device: Heart Rate Variability,HRV - ANSWatch
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.
Device: Traditional Chinese Medicine Tongue Imaging
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2025/01/18 (4th week)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Observe the differences in physical constitution and tongue diagnosis between patients with myasthenia and healthy people.
Time Frame: 2025/01/18 (4th week)
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.
2025/01/18 (4th week)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yi Ting Yeh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2023

Primary Completion (Estimated)

January 17, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

August 8, 2024

First Submitted That Met QC Criteria

December 30, 2024

First Posted (Actual)

December 31, 2024

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20221019R

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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