DACOS: The Dampness Syndrome of Chinese Medicine Cohort Study

Sponsor

Guangzhou University of Traditional Chinese Medicine (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05315895

Collaborator

State Key Laboratory of Dampness Syndrome of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Other)

100,000

Enrollment

69.8

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Disease Cancer Dementia Alzheimers Metabolic Disease Aging Alzheimer Disease, Early Onset	Other: natural aging process

Detailed Description

DACOS is a national large- scale, longitudinal, multi-center, prospective, cohort study of natural person aged 35 to 75. The baseline survey and the follow-up surveys will be conducted in 5 areas covering the eastern, northern, western, southern and middle parts of China. In this study 100,000 natural person will be regularly followed up for 5 years(visited once a year), with the loss rate ≤15%. Three parts will be carried in the form of interview, physical examination and biological sample collection. During the interview, the investigators plan to do some questionnaires to learn participants' demographic characteristics, life style, disease history, healthy condition(EQ-5D-5L, SDS,), cognition state(AD-8, MMSE, MoCA) and the results of TCM syndrome differentiation(Score of Dampness syndrome and TCM constitution scale). All biological specimens (including blood, feces, urine, saliva and tongue coating) will be collected and stored in the biological resource center until researchers request their use. With the building up of this cohort, the researchers will analyze the causality between dampness syndrome and specific chronic diseases such as diabetes, coronary heart disease, cancer, dementia and so on.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

100000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Multi-Center Prospective Cohort Study of Dampness Syndrome in China

Anticipated Study Start Date :

Jun 6, 2022

Anticipated Primary Completion Date :

Dec 30, 2027

Anticipated Study Completion Date :

Mar 30, 2028

Arms and Interventions

Arm	Intervention/Treatment
general population general population in a specific area and specifc time range.	Other: natural aging process 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.

Arm

Intervention/Treatment

general population

general population in a specific area and specifc time range.

Other: natural aging process

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.

Outcome Measures

Primary Outcome Measures

emerging diseases [through study completion, an average of 1 year]
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.

Secondary Outcome Measures

Montreal Cognitive Assessment(MoCA) [through study completion, an average of 1 year]
MoCA is a brief, 30-question test that helps healthcare professionals detect cognitive impairments very early on, allowing for faster diagnosis and patient care. MoCA is the most sensitive test available for detecting Alzheimer's disease, measuring executive functions and multiple cognitive domains. The value range 0-30: higher scores mean a better Cognitine. The score above 26 is considered the normal congnitive level
European Quality of Life 5-dimensional questionnaire (EQ-5D-5L) [through study completion, an average of 1 year]
The EQ-5D comprises five dimensions of health: mobility, ability to self-care, ability to undertake usual activities, pain and discomfort, and anxiety and depression. . EQ-5D-5L, includes five levels of severity for each dimension (no problems, slight problems, moderate problems, severe problems, and extreme problems). The value range 0-100: higher scores mean a worse outcome.
Mini-Mental State Exam (MMSE) [through study completion, an average of 1 year]
MMSE is a widely used test of cognitive function among the elderly; it includes tests of orientation, attention, memory, language and visual-spatial skills. The value range 0-30: higher scores mean a better Cognitine.
interview questionnaire [through study completion, an average of 1 year]
Demographic characteristic, life style. disease history, allergies will be involoved.
change of the blood routine results [through study completion, an average of 1 year]
WBC, RBC, PLT , HB, NEUT% and LYM% will be tested and recorded. Above or below each mormal value will be considered as abnormal.
urine routine [through study completion, an average of 1 year]
urinary WBC and urinary RBC will be observed. negative or below 5/HP is normal. BLO and GLU and PRO in urine will also be test. Negative is normal.
change of faeces routine [through study completion, an average of 1 year]
cells in faeces will be tested such as RBC and WBC. Negative occult blood（FOB) is difined normal.
change of hepatic function [an average of 1 year]
The researchers will check the results of ALT and AST. TBil, DBIL, TBA and TP, ALB. Any indices above or below the criteria range is defined as abnormal. Every time point investigators will record the change of these indices.
change of renal function [an average of 1 year]
The researchers will check the results of Cr， BUN, TC， LDL， HDL,UA and fasting blood glucose，glycosylanted. Any indices above or below the criteria range is defined as abnormal. Every time point investigators will record the change of these indices.
change of CRP [an average of 1 year]
change of CPP
change of Hcy [an average of 1 year]
change of Hcy
change of thyroid function [an average of 1 year]
change of TSH ,FT3, FT4
change of Vit B12 and folic acid [an average of 1 year]
change of Vit B12
change of coagulation function [an average of 1 year]
change of PT, INR,TT,APTT，FIB
change of abdominal ultrasound [an average of 1 year]
change of abdominal ultrasound
change of gynecologic ultrasound [an average of 1 year]
change of gynecologic ultrasound
change of ECG [an average of 1 year]
The researchers will check the change of P, QRS and ST segments separately in electrocardiogram.
change of brain MRI [an average of 1 year]
change of brain MRI. The investigators will focus on the change of hippocampal volume and the spacing of temporal sulcus gyrus.

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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;

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Guangzhou University of Traditional Chinese Medicine
State Key Laboratory of Dampness Syndrome of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine