Clinical trial NCT06754020: TCM Tongue Diagnosis and Syndrome Differentiation in Myasthenia Gravis Compared to Healthy Controls
Official title: Application of Artificial Intelligence for Precision Medicine in TCM Tongue Diagnosis and Syndrome Differentiation in Myasthenia Gravis Compared to Healthy Controls
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myasthenia Gravis
Keywords: Myasthenia Gravis
traditional Chinese medicine
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
First posted: 2024-12-31
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: What are the differences in tongue diagnosis in traditional Chinese medicine between the disease group and the healthy population?
timeFrame: 2025/01/18 (4th week)
Secondary outcomes:
measure: Observe the differences in physical constitution and tongue diagnosis between patients with myasthenia and healthy people.
timeFrame: 2025/01/18 (4th week)
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Yi Ting Yeh
state: Tamsui District
Study officials:
References: