Diagnostic Performance of an AI-based Model for TCM Constitution Classification Using Ophthalmic Imaging

NCT ID: NCT07127939

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1024 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2028-12-31

Brief Summary

To evaluate the diagnostic performance of a multimodal deep learning model for identifying biased Traditional Chinese Medicine (TCM) constitutions using ophthalmic imaging

Detailed Description

The identification of Traditional Chinese Medicine (TCM) constitutions is a central principle of its preventive medicine philosophy (Zhi Wei Bing). Yet, current diagnostic methods-relying on subjective questionnaires and expert interpretation-are not scalable, objective, or efficient enough for widespread clinical use. While artificial intelligence has been applied to traditional inputs like tongue and pulse analysis, these approaches have failed to overcome fundamental issues of data standardization and objectivity. Consequently, a critical gap exists: there is no modern, reliable, and scalable tool to assess TCM constitutions, preventing the full integration of this valuable theory into contemporary healthcare.

This study aims to bridge that gap by developing and validating a novel deep learning model for "intelligent ocular diagnosis" of TCM constitutions. By using highly objective and information-rich ophthalmic imaging, our approach circumvents the subjectivity inherent in traditional methods. The primary objective is to create a fully automated, high-throughput system capable of accurately classifying TCM constitutions. The successful completion of this project will not only provide the first objective tool for TCM constitution analysis but will also establish a powerful framework for the early prediction and personalized management of chronic diseases, creating a new paradigm for integrated Chinese and Western medicine.

Conditions

Ophthalmic Imaging; Deep Learning; Artificial Intelligence (AI); Traditional Chinese Medicine Constitution

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Patients with Chronic Systemic Diseases

This cohort consists of participants with a confirmed diagnosis of one or more chronic systemic diseases. These include cardiovascular diseases, malignant tumors, diabetes mellitus, and chronic respiratory diseases, as defined by the study's inclusion criteria.

AI-based Ocular Diagnosis Model for TCM Constitutions

Intervention Type: DIAGNOSTIC_TEST

AI-based Ocular Diagnosis Model for Identifying Traditional Chinese Medicine (TCM) Constitutions

Healthy Control Group

This cohort consists of volunteers with no history of major chronic systemic diseases. Participants are confirmed to have no conditions requiring continuous medical intervention or causing limitation of daily activities, serving as the control group for this study.

AI-based Ocular Diagnosis Model for TCM Constitutions

Intervention Type: DIAGNOSTIC_TEST

AI-based Ocular Diagnosis Model for Identifying Traditional Chinese Medicine (TCM) Constitutions

Interventions

AI-based Ocular Diagnosis Model for TCM Constitutions

AI-based Ocular Diagnosis Model for Identifying Traditional Chinese Medicine (TCM) Constitutions

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Age: Participants aged between 18 and 60 years;

2. Chronic Systemic Diseases: Defined according to the standards of the United States National Center for Chronic Disease Prevention and Health Promotion and the "Healthy China 2030" planning outline issued by the State Council. These are characterized as conditions lasting one year or longer that require continuous medical care, limit daily activities, or both. The four major chronic diseases in China include:Cardiovascular and cerebrovascular diseases,Malignant neoplasms,Diabetes mellitus and Chronic respiratory diseases;

3. Cardiovascular and Cerebrovascular Diseases: This category includes:Hypertension: Stable hypertension without acute episodes, defined as systolic blood pressure ≥140 mmHg, diastolic blood pressure ≥90 mmHg, or currently undergoing antihypertensive treatment.Coronary Heart Disease: Diagnosed based on a history of coronary heart disease or confirmed through imaging evidence such as coronary angiography or CT angiography.

Heart Failure: Classified as New York Heart Association (NYHA) functional class II-IV with a left ventricular ejection fraction <40%.Stroke: Diagnosed based on a history of ischemic or hemorrhagic stroke or confirmed through imaging evidence such as MRI or CT scans;

4. Malignant Neoplasms: Participants with newly diagnosed, recurrent, metastatic malignant tumors, or those currently receiving specific treatments (e.g., chemotherapy, radiotherapy, immunotherapy), confirmed by histological or cytological examinations;

5. Diabetes Mellitus: Participants meeting at least one of the following criteria:

Fasting blood glucose ≥7.0 mmol/L (126 mg/dL),2-hour post-oral glucose tolerance test blood glucose ≥11.1 mmol/L (200 mg/dL),Hemoglobin A1c ≥6.5%,Random blood glucose ≥11.1 mmol/L (200 mg/dL) accompanied by typical symptoms (e.g., polydipsia, polyuria, weight loss);

6. Chronic Respiratory Diseases: This category includes:Chronic Obstructive Pulmonary Disease (COPD): Post-bronchodilator FEV₁/FVC <0.70 and FEV₁ <80% of the predicted value, accompanied by at least one clinical symptom such as chronic cough, sputum production, or dyspnea.Asthma: Reversible airflow limitation, defined as a post-bronchodilator FEV₁ increase of ≥12% and ≥200 ml, accompanied by at least one clinical symptom such as recurrent wheezing, dyspnea, chest tightness, or cough;

7. Healthy Subjects: Individuals who have not experienced any systemic diseases within the past year that require continuous medical care, limit daily activities, or both;

8. Clear Diagnosis Based on Traditional Chinese Medicine and Western Medicine: Participants must have a definitive diagnosis established through both Traditional Chinese Medicine and Western Medicine methodologies;

9. Absence of Other Ocular or Systemic Organic Diseases: Participants should have no other ocular diseases and/or systemic organic lesions that significantly affect the acquisition of ocular imaging.

Exclusion Criteria

1. Incomplete Clinical Data Supporting Diagnosis: Participants for whom the clinical data necessary to substantiate the diagnosis are incomplete;

2. Significant Opacification of Other Ocular Optical Systems: Individuals presenting with pronounced obscurations in other ocular optical systems (e.g., severe corneal opacification, nuclear cataract grade IV or higher, severe vitreous hemorrhage or opacification) that impede the completion of comprehensive ocular examinations;

3. Acute Systemic Organic Diseases: Patients concurrently suffering from acute systemic organic conditions (such as acute infections or decompensated organ failure) that prevent participation in the constitution identification procedures;

4. Pregnancy or Lactation: Individuals who are pregnant or currently breastfeeding.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Second Affiliated Hospital of Nanchang University

OTHER

Sponsor Role: lead

Responsible Party

Jian Xiong

Associate research fellow; Attending physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jiang Xiong

Role: CONTACT

894040417@qq.com

+8618170906556

Facility Contacts

Jiang Xiong

Role: primary

894040417@qq.com

+8618170906556

Fu Gui

Role: backup

564436578@qq.com

+8613879101919

Other Identifiers

[2025] NO.(85)

Identifier Type: -

Identifier Source: org_study_id