Prospective Cohort of Integrated Traditional Chinese and Western Medicine in China

To further explore the application prospects of integrated Traditional Chinese and Western medicine in chronic disease prevention and control and health management, this study intends to establish a large, prospective, integrated Traditional Chinese and Western medicine cohort in Hubei Province. This study will conduct long-term follow-up and multi-dimensional data collection to systematically reveal the associations between Traditional Chinese Medicine (TCM) constitution types and chronic diseases, the aging process, and multi-morbidity, thereby developing an integrated health management strategy with local characteristics. This study will fill the current gap in systematic evidence linking TCM constitutions to the prevalence of modern diseases, providing a solid demographic and biological foundation for the integrated development of Traditional Chinese and Western medicine. It will also contribute to meeting the needs for early disease warning, early intervention, and personalized care under the "Healthy China" strategic goal.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiovascular Diseases; Respiratory Tract Diseases; Endocrine System Diseases; Cancer; Death

• Study Type: Observational
• Enrollment (Estimated): 1000000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Targeting urban and rural residents across multiple regions in Hubei Province, this study plans to recruit 1 million participants. Standardized protocols will be employed for baseline questionnaire surveys, physical examinations, and biological sample collection.

Description

Inclusion Criteria:

Age: Participants aged 30 to 74 years

Physical Functionality: Free from severe physical disabilities impacting mobility or communication, with preserved ability to comprehend and respond to study procedures

Informed Consent: Capable of providing written informed consent voluntarily after receiving full study disclosure

Exclusion Criteria:

Residents living in functional areas (e.g., work sheds, military units, student dormitories, nursing homes, etc.)

Individuals unable to communicate normally

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Prospective Cohort of Integrated Traditional Chinese and Western Medicine in China	From enrollment to the 10-year follow-up
Incidence of major chronic diseases (coronary heart disease, stroke, diabetes, COPD, lung cancer, colorectal cancer, gastric cancer, liver cancer, and esophageal cancer)	From baseline (enrollment) to 10-year follow-up Measurement Tool: Standardized physician-adjudicated diagnosis based on ICD-10 codes, confirmed through hospital electronic medical records and disease registries

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	Time Frame: From baseline to 10-year follow-up Measurement Tool: Death registry linkage and hospital records Unit of Measure: Mortality rate per 1,000 person-years	From baseline to 10-year follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cause-specific mortality (cardiovascular, cancer, respiratory, metabolic)	Time Frame: From baseline to 10-year follow-up Measurement Tool: Death registry and ICD-10 coded cause of death Unit of Measure: Mortality rate per 1,000 person-years	From baseline to 10-year follow-up
Prevalence and progression of multimorbidity (≥2 chronic conditions)	Time Frame: Baseline to 10-year follow-up Measurement Tool: Questionnaire survey and physician-adjudicated diagnosis using ICD-10 Unit of Measure: % of participants with multimorbidity	Baseline to 10-year follow-up

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology
• Collaborators: Hubei Hospital of Traditional Chinese Medicine; Hubei Provincial Center for Disease Control and Prevention; Wuhan Center for Disease Control and Prevention; Hubei College of Traditional Chinese Medicine; Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: September 20, 2025
• First Submitted That Met QC Criteria: September 20, 2025
• First Posted (Estimated): September 29, 2025

Study Record Updates

• Last Update Posted (Estimated): October 2, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms; Cardiovascular Diseases; Respiratory Tract Diseases; Death; Endocrine System Diseases
• Other Study ID Numbers: 2023ZD0S09900)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No