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

NCT06754020 | Recruiting

• 1 other identifier: 20221019R
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Myasthenia Gravis

Keywords

Myasthenia Gravis; traditional Chinese medicine

Outcome Measures

Primary Outcomes (1)

• What are the differences in tongue diagnosis in traditional Chinese medicine between the disease group and the healthy population?

  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.

  2025/01/18 (4th week)

Secondary Outcomes (1)

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

  2025/01/18 (4th week)

Study Arms (2)

Disease Group

EXPERIMENTAL

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

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

**Healthy Control Group**

EXPERIMENTAL

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

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

Interventions

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.

**Healthy Control Group**; Disease Group

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.

**Healthy Control Group**; Disease Group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yi Ting Yeh: lead

Study Sites (1)

Yi Ting Yeh

New Taipei City, Tamsui District, 251, Taiwan

RECRUITING

MeSH Terms

Conditions

Myasthenia Gravis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

YI TIMG YEH

CONTACT

+866-952-166-103; reinating90@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: December 31, 2024
• Study Start: January 17, 2023
• Primary Completion (Estimated): January 17, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

TW (1)