The Dampness Syndrome of Chinese Medicine Cohort Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Chronic Disease, Cancer, Dementia Alzheimers, Metabolic Disease, Aging, Alzheimer Disease, Early Onset

Intervention / Treatment
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* Other: natural aging process


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| general population<br>general population in a specific area and specifc time range. | Other: natural aging process<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montreal Cognitive Assessment(MoCA) | 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 | through study completion, an average of 1 year | 
| European Quality of Life 5-dimensional questionnaire (EQ-5D-5L) | 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. | through study completion, an average of 1 year | 
| Mini-Mental State Exam (MMSE) | 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. | through study completion, an average of 1 year | 
| interview questionnaire | Demographic characteristic, life style. disease history, allergies will be involoved. | through study completion, an average of 1 year | 
| change of the blood routine results | WBC, RBC, PLT , HB, NEUT% and LYM% will be tested and recorded. Above or below each mormal value will be considered as abnormal. | through study completion, an average of 1 year | 
| urine routine | 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. | through study completion, an average of 1 year | 
| change of faeces routine | cells in faeces will be tested such as RBC and WBC. Negative occult blood（FOB) is difined normal. | through study completion, an average of 1 year | 
| change of hepatic function | 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. | an average of 1 year | 
| change of renal function | 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. | an average of 1 year | 
| change of CRP | change of CPP | an average of 1 year | 
| change of Hcy | change of Hcy | an average of 1 year | 
| change of thyroid function | change of TSH ,FT3, FT4 | an average of 1 year | 
| change of Vit B12 and folic acid | change of Vit B12 | an average of 1 year | 
| change of coagulation function | change of PT, INR,TT,APTT，FIB | an average of 1 year | 
| change of abdominal ultrasound | change of abdominal ultrasound | an average of 1 year | 
| change of gynecologic ultrasound | change of gynecologic ultrasound | an average of 1 year | 
| change of ECG | The researchers will check the change of P, QRS and ST segments separately in electrocardiogram. | an average of 1 year | 
| change of brain MRI | change of brain MRI. The investigators will focus on the change of hippocampal volume and the spacing of temporal sulcus gyrus. | an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dampness Syndrome, multi-center study, prospective cohort study