NCT05315895

Brief Summary

The researchers plain to build a large-scale, longitudinal, prospective cohort characterized by TCM dampness syndrome. With the biobank of this cohort the investigators want to find the causality between TCM dampness syndrome and clinical chronic diseases and a new way to treat clinical disease.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100,000

participants targeted

Target at P75+ for all trials

Timeline
23mo left

Started Jun 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress67%
Jun 2022Mar 2028

First Submitted

Initial submission to the registry

March 11, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 7, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

June 6, 2022

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2028

Last Updated

November 15, 2022

Status Verified

November 1, 2022

Enrollment Period

5.6 years

First QC Date

March 11, 2022

Last Update Submit

November 14, 2022

Conditions

Keywords

Dampness Syndromemulti-center studyprospective cohort study

Outcome Measures

Primary Outcomes (1)

  • emerging diseases

    This study will pay attention to the emerging situation of clinical chronic diseases, such as cancer, diabetes, hypertension, coronary heart disease, dementia, etc. Each follow-up the researchers will record the incidence of the emerging diseases of interviewees' by questionnaire including the name of the disease, time of onset and treatments.

    through study completion, an average of 1 year

Secondary Outcomes (18)

  • Montreal Cognitive Assessment(MoCA)

    through study completion, an average of 1 year

  • European Quality of Life 5-dimensional questionnaire (EQ-5D-5L)

    through study completion, an average of 1 year

  • Mini-Mental State Exam (MMSE)

    through study completion, an average of 1 year

  • interview questionnaire

    through study completion, an average of 1 year

  • change of the blood routine results

    through study completion, an average of 1 year

  • +13 more secondary outcomes

Study Arms (1)

general population

general population in a specific area and specifc time range.

Other: natural aging process

Interventions

To observe the relationship between new cases of diseases and health status of people exposed to different factors such as life style, alcohol consumption, eating habits, etc.

general population

Eligibility Criteria

Age35 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

general population in a specific area and specifc time range. Such as civil servants of Guangdong Province. Medical workers in Xinjiang.

You may qualify if:

  • Residents aged 30 to 79, whose residence is consistent with their registered permanent residence location;
  • Residents who voluntarily participate in the project, agree to the collection of their biological information, and sign the informed consent form;
  • Residents who have no mental illness and other related diseases, and display a normal ability of expression and understanding;

You may not qualify if:

  • Residents who reject collaboration;
  • Residents who allow no follow-up visits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong Province Hospital of Tradtional Chinese Medicine

Guangzhou, Guangdong, 510120, China

RECRUITING

Related Publications (1)

  • Li M, Liu N, Jiang G, Zeng H, Guo J, Wu D, Zhou H, Wen Z, Zhou L. Health-related quality of life in populations with diabetes, prediabetes, and normal glycemic levels in Guangzhou, China: a cross-sectional study. Front Endocrinol (Lausanne). 2025 May 23;16:1518204. doi: 10.3389/fendo.2025.1518204. eCollection 2025.

Biospecimen

Retention: SAMPLES WITH DNA

All biological specimens (including blood, feces, urine, saliva and tongue coating) will be stored in the biological resource center of the our research centers after written informed consent obtained from all subjects who voluntarily participated in this clinical study.

MeSH Terms

Conditions

Chronic DiseaseNeoplasmsAlzheimer DiseaseMetabolic Diseases

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersNutritional and Metabolic Diseases

Central Study Contacts

Jianwen Guo, MD

CONTACT

Bin Zhang, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2022

First Posted

April 7, 2022

Study Start

June 6, 2022

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

March 30, 2028

Last Updated

November 15, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will share

If you need to access or use the population information database and biological sample database, you must go through strict application and approval processes at first

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
After half year of the baseline and follow-ups data completing.
Access Criteria
A professional qualification panel determines whether the visitor is qualified to view and use the repository.

Locations