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

NCT ID: NCT06754020

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-17
• Study Completion Date: 2026-06-17

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.

Conditions

Myasthenia Gravis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Disease Group

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

Group Type: EXPERIMENTAL

Heart Rate Variability,HRV - ANSWatch

Intervention Type: 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

Intervention Type: 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.

**Healthy Control Group**

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

Group Type: EXPERIMENTAL

Heart Rate Variability,HRV - ANSWatch

Intervention Type: 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

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yi Ting Yeh

OTHER

Sponsor Role: lead

Responsible Party

Yi Ting Yeh

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Yi Ting Yeh

New Taipei City, Tamsui District, Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

YI TIMG YEH

Role: CONTACT

reinating90@gmail.com

+866-952-166-103

Facility Contacts

YI TING YEH

Role: primary

ting79503@gmail.com

+886-952-166-103

Other Identifiers

20221019R

Identifier Type: -

Identifier Source: org_study_id