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

Yi Ting Yeh

Status: Enrolling

Conditions: Myasthenia Gravis

Treatments: Device: Heart Rate Variability,HRV - ANSWatch; Device: Traditional Chinese Medicine Tongue Imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT06754020

20221019R

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Disease Group

Experimental group

Description:

Participants with myasthenia gravis will be recruited and assessed in the Neurology Department's outpatient clinic and wards at Shin Kong Hospital.

Treatment:

Device: Traditional Chinese Medicine Tongue Imaging

Device: Heart Rate Variability,HRV - ANSWatch

**Healthy Control Group**

Experimental group

Description:

The healthy control group will be recruited from community settings and universities in Taipei City.

Treatment:

Device: Traditional Chinese Medicine Tongue Imaging

Device: Heart Rate Variability,HRV - ANSWatch