Recruiting

Artificial Intelligence for TCM Constitution Classification through Eye Imaging

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What is being collected

Data Collection

Collected at a single point in time - Cross-sectional
Who is being recruted

From 18 to 45 Years
See all eligibility criteria
How is the trial designed

Other

Utilizing specific methods not covered by standard models in order to address unique research questions.
Observational
Study Start: July 2025
See protocol details

Summary

Principal SponsorSecond Affiliated Hospital of Nanchang University
Study ContactJiang Xiong
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2025

Actual date on which the first participant was enrolled.

The study focuses on improving how Traditional Chinese Medicine (TCM) constitutions are diagnosed by using advanced technology. TCM constitutions are typically identified through subjective methods like questionnaires and expert opinions, which can be inconsistent and not suitable for widespread use. This research aims to create a modern, reliable, and scalable tool using artificial intelligence to analyze eye images. This new method hopes to offer a more objective and efficient way to assess TCM constitutions, which could help integrate these ancient practices more effectively into modern healthcare systems, potentially assisting in early disease prediction and personalized treatment plans. Participants in the study will have their eye images taken, which will be analyzed using a new deep learning model. This model uses ophthalmic imaging to classify TCM constitutions automatically, without the need for traditional subjective methods. The study measures its success by evaluating how accurately the AI model can identify these constitutions, using a statistical measure called the area under the receiver operating characteristic (AUROC). This approach is expected to provide a reliable foundation for merging TCM with contemporary medical practices, enhancing both diagnosis and treatment options.

Official TitleDiagnostic Performance of an Artificial Intelligence Driven Model for Traditional Chinese Medicine Constitution Classification Using Ophthalmic Imaging
NCT07127939
Principal SponsorSecond Affiliated Hospital of Nanchang University
Study ContactJiang Xiong
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1024 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other

Some studies use unique or mixed approaches that don't fit standard categories. These may include innovative observational methods or studies tailored to specific research questions.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

The Second Affiliated Hospital of Nanchang University

Nanchang, ChinaOpen The Second Affiliated Hospital of Nanchang University in Google Maps
Recruiting
One Study Center
Artificial Intelligence for TCM Constitution Classification through Eye Imaging | PatLynk