TCM Constitution TheoryNCT07308366
Research on an Intelligent Health Recommendation System for Chronic Disease Comorbidity Integrating TCM
An observational study of TCM Constitution Theory, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine.
Trial summary
1. Construct a Traditional Chinese Medicine (TCM) constitution database, clarify the distribution patterns of TCM constitution in populations with comorbid "three-high" conditions (hypertension, hyperlipidemia, and hyperglycemia) and their associations with metabolic indicators. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- TCM Constitution Theory
- What is being tested?
- Multimodal AI Models
- How many people
- 195 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2025to 30 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A standardized survey was conducted using the Classification and Assessment Criteria of Traditional Chinese Medicine Constitution (Standard of the China Association of Chinese Medicine)constitution identification scale. Trained TCM practitioners and nursing staff performed constitution assessment to identify the dominant constitution type and any coexisting constitution types. Additionally, patient basic information, disease diagnosis details, and recent metabolic indicators such as blood pressure, fasting blood glucose, glycosylated hemoglobin, and blood lipid levels were collected.
Who may be able to join
- Age ≥ 18 years; Clear diagnosis of hypertension, type 2 diabetes, and hyperlipidemia, and a comorbid condition involving all three diseases; Stable disease condition with no recent acute complications; Capable of completing questionnaires, and willing to provide informed consent to voluntarily participate in the study.
Who cannot join
- Patients in the acute phase of the three high diseases (hypertension, diabetes, hyperlipidemia) or with severe complications (such as acute myocardial infarction or stroke); Patients with other major diseases that may affect constitution assessment or intervention implementation, such as malignant tumors, severe liver or kidney dysfunction, active tuberculosis, or mental illness; Patients who have received systematic Traditional Chinese Medicine treatment (e.g., herbal decoctions or acupuncture) within the past month, which may influence the initial assessment of constitution type; Pregnant or lactating women; Individuals unable to cooperate with measurements, with language communication barriers, or cognitive impairments; Patients participating in other interventional clinical studies.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Research on an Intelligent Health Preservation Recommendation System for Chronic Disease Comorbidity Based on the Integration of Traditional Chinese Medicine Constitution Database and Multimodal Large Language Models
- Construct a Traditional Chinese Medicine (TCM) constitution database, clarify the distribution patterns of TCM constitution in populations with comorbid "three-high" conditions (hypertension, hyperlipidemia, and hyperglycemia) and their associations with metabolic indicators. Establish a "constitution-comorbidity-metabolism" relationship model to provide a basis for personalized intervention and the development of an AI platform.
- Develop the AI-HEALS system by integrating the TCM constitution database with multimodal large language models. This system will generate personalized intervention plans and provide intelligent interactive Q\&A capabilities to enhance patient intervention adherence.
- Evaluate the clinical application effectiveness of the AI-HEALS system, explore the relationship between changes in constitution and intervention outcomes, and validate the TCM intervention pathway of "regulating constitution to promote health." This will provide both theoretical and practical guidance for the dynamic regulation and precise intervention of TCM constitution.
Read the detailed description
This project combines Traditional Chinese Medicine (TCM) constitution theory with large language models (LLMs) through interdisciplinary integration, constructing a dynamically empowered intelligent health recommendation system for TCM. It promotes the deep integration of the "treatment based on constitution differentiation" concept with artificial intelligence. The significance of this research is mainly reflected in the following two aspects:
At the theoretical level, this study helps expand the knowledge representation and computational modeling methods of TCM constitution theory within the framework of modern artificial intelligence. It advances the application and transformation of the TCM concept of "preventive treatment" in big data and intelligent reasoning scenarios, provides new perspectives for research on the mechanisms linking TCM constitution and chronic disease comorbidities, and fosters cross-integration between TCM theoretical systems and modern medical information science.
At the practical level, the research relies on real clinical data and multimodal AI models to establish a structured, standardized TCM constitution database. It develops a health education system with individualized identification, intelligent recommendation, and dynamic intervention functions, suitable for personalized management and early warning in populations with chronic disease comorbidities. The project outcomes will help enhance individual health literacy and quality of life, alleviate the burden of chronic diseases, promote the practical application of TCM in primary healthcare services and digital medicine, and demonstrate significant social value and broad prospects for widespread adoption.
- Conditions
- TCM Constitution Theory
- Being tested
- Multimodal AI Models
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal AI ModelsOther
Construct a Traditional Chinese Medicine (TCM) constitution database, clarify the distribution patterns of TCM constitution in populations with comorbid "three-high" conditions (hypertension, hyperlipidemia, and hyperglycemia) and their associations with metabolic indicators. Establish a "constitution-comorbidity-metabolism" relationship model to provide a basis for personalized intervention and the development of an AI platform.
What is being measured
The primary outcome is the main question the study is designed to answer.
Traditional Chinese Medicine (TCM) Constitution Database
Develop the AI-HEALS intelligent intervention platform, equipped with functions such as constitution identification, intelligent recommendations, and interactive Q\&A, achieving a Q\&A accuracy rate of over 90%.
Measured: Observation period: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start20 Dec 2025 (estimated)
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TCM Constitution TheoryStudies of the same condition, open and under way.
- More trials run by The Fourth Affiliated Hospital of Zhejiang University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 195 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07308366
- Sponsor's protocol ID
- KY-2025-295
- Status last verified
- Dec 2025
- First submitted
- 15 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on an Intelligent Health Preservation Recommendation System for Chronic Disease Comorbidity Based on the Integration of Traditional Chinese Medicine Constitution Database and Multimodal Large Language Models
- ClinicalTrials.gov ID
- NCT07308366
- Acronym / sponsor ID
- KY-2025-295
- Conditions
- TCM Constitution Theory
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 195 participants (estimated)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 20 Dec 2025 (estimated)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Construct a Traditional Chinese Medicine (TCM) constitution database, clarify the distribution patterns of TCM constitution in populations with comorbid "three-high" conditions (hypertension, hyperlipidemia, and hyperglycemia) and their associations with metabolic indicators. Establish a "constitution-comorbidity-metabolism" relationship model to provide a basis for personalized intervention and the development of an AI platform.
- Develop the AI-HEALS system by integrating the TCM constitution database with multimodal large language models. This system will generate personalized intervention plans and provide intelligent interactive Q\&A capabilities to enhance patient intervention adherence.
- Evaluate the clinical application effectiveness of the AI-HEALS system, explore the relationship between changes in constitution and intervention outcomes, and validate the TCM intervention pathway of "regulating constitution to promote health." This will provide both theoretical and practical guidance for the dynamic regulation and precise intervention of TCM constitution.
Detailed description
This project combines Traditional Chinese Medicine (TCM) constitution theory with large language models (LLMs) through interdisciplinary integration, constructing a dynamically empowered intelligent health recommendation system for TCM. It promotes the deep integration of the "treatment based on constitution differentiation" concept with artificial intelligence. The significance of this research is mainly reflected in the following two aspects:
At the theoretical level, this study helps expand the knowledge representation and computational modeling methods of TCM constitution theory within the framework of modern artificial intelligence. It advances the application and transformation of the TCM concept of "preventive treatment" in big data and intelligent reasoning scenarios, provides new perspectives for research on the mechanisms linking TCM constitution and chronic disease comorbidities, and fosters cross-integration between TCM theoretical systems and modern medical information science.
At the practical level, the research relies on real clinical data and multimodal AI models to establish a structured, standardized TCM constitution database. It develops a health education system with individualized identification, intelligent recommendation, and dynamic intervention functions, suitable for personalized management and early warning in populations with chronic disease comorbidities. The project outcomes will help enhance individual health literacy and quality of life, alleviate the burden of chronic diseases, promote the practical application of TCM in primary healthcare services and digital medicine, and demonstrate significant social value and broad prospects for widespread adoption.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A standardized survey was conducted using the Classification and Assessment Criteria of Traditional Chinese Medicine Constitution (Standard of the China Association of Chinese Medicine)constitution identification scale. Trained TCM practitioners and nursing staff performed constitution assessment to identify the dominant constitution type and any coexisting constitution types. Additionally, patient basic information, disease diagnosis details, and recent metabolic indicators such as blood pressure, fasting blood glucose, glycosylated hemoglobin, and blood lipid levels were collected.
Key inclusion criteria (1 listed)
- Age ≥ 18 years; Clear diagnosis of hypertension, type 2 diabetes, and hyperlipidemia, and a comorbid condition involving all three diseases; Stable disease condition with no recent acute complications; Capable of completing questionnaires, and willing to provide informed consent to voluntarily participate in the study.
Key exclusion criteria (1 listed)
- Patients in the acute phase of the three high diseases (hypertension, diabetes, hyperlipidemia) or with severe complications (such as acute myocardial infarction or stroke); Patients with other major diseases that may affect constitution assessment or intervention implementation, such as malignant tumors, severe liver or kidney dysfunction, active tuberculosis, or mental illness; Patients who have received systematic Traditional Chinese Medicine treatment (e.g., herbal decoctions or acupuncture) within the past month, which may influence the initial assessment of constitution type; Pregnant or lactating women; Individuals unable to cooperate with measurements, with language communication barriers, or cognitive impairments; Patients participating in other interventional clinical studies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal AI ModelsConstruct a Traditional Chinese Medicine (TCM) constitution database, clarify the distribution patterns of TCM constitution in populations with comorbid "three-high" conditions (hypertension, hyperlipidemia, and hyperglycemia) and their associations with metabolic indicators. Establish a "constitution-comorbidity-metabolism" relationship model to provide a basis for personalized intervention and the development of an AI platform. | Other | – |
Primary outcome
Traditional Chinese Medicine (TCM) Constitution Database
Time frame: Observation period: 3 years
Develop the AI-HEALS intelligent intervention platform, equipped with functions such as constitution identification, intelligent recommendations, and interactive Q\&A, achieving a Q\&A accuracy rate of over 90%.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of TCM Constitution Theory, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact qingqing liu (13858089867, qingliuq@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Traditional Chinese Medicine (TCM) Constitution Database (time frame: Observation period: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.