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NCT Number: NCT06754020

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.

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Key information

Conditions

Myasthenia Gravis Autoimmune Diseases Autoimmune Diseases of the Nervous System Immune System Diseases Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurodegenerative Diseases Neuromuscular Diseases Neuromuscular Junction Diseases Paraneoplastic Syndromes Paraneoplastic Syndromes, Nervous System

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Heart Rate Variability,HRV - ANSWatch

Device

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 Imaging

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

YI TIMG YEH

CONTACT

[email protected]

+866-952-166-103

Sponsors and collaborators

Lead sponsor

Yi Ting Yeh

Other

Registry information

Official study title

Application of Artificial Intelligence for Precision Medicine in TCM Tongue Diagnosis and Syndrome Differentiation in Myasthenia Gravis Compared to Healthy Controls

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Dec 31, 2024
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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