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

Not Applicable

Recruiting

• Conditions: Myasthenia Gravis

• Registration Number: NCT06754020
• Lead Sponsor: Yi Ting Yeh

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.

Study Timeline

• Study Start: 2023-01-17
• Study First Submitted: 2024-08-08
• Study First Submitted QC: 2024-12-30
• Study First Posted: 2024-12-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-16
• Last Update Posted: 2025-03-18
• Primary Completion: 2026-01-17
• Study Completion: 2026-06-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
What are the differences in tongue diagnosis in traditional Chinese medicine between the disease group and the healthy population?	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 Outcome Measures

Name	Time	Method
Observe the differences in physical constitution and tongue diagnosis between patients with myasthenia and healthy people.	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.

Trial Locations

Locations (1)

Yi Ting Yeh; 🇨🇳 New Taipei City, Tamsui District, Taiwan