The Dampness Syndrome of Chinese Medicine Cohort Study

Recruiting

• Conditions: Chronic Disease; Aging; Dementia Alzheimers; Metabolic Disease; Cancer; Alzheimer Disease, Early Onset
• Interventions: Other: natural aging process

• Registration Number: NCT05315895
• Lead Sponsor: Guangzhou University of Traditional Chinese Medicine

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.

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 Timeline

• Study First Submitted: 2022-03-11
• Study First Submitted QC: 2022-03-30
• Study First Posted: 2022-04-07
• Study Start: 2022-06-06
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-14
• Last Update Posted: 2022-11-15
• Primary Completion: 2027-12-30
• Study Completion: 2028-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100000

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
general population	natural aging process	general population in a specific area and specifc time range.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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 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.
change of thyroid function	an average of 1 year	change of TSH ,FT3, FT4
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.
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.
interview questionnaire	through study completion, an average of 1 year	Demographic characteristic, life style. disease history, allergies will be involoved.
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 abdominal ultrasound	an average of 1 year	change of abdominal ultrasound
change of ECG	an average of 1 year	The researchers will check the change of P, QRS and ST segments separately in electrocardiogram.
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
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.
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 gynecologic ultrasound	an average of 1 year	change of gynecologic ultrasound
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 CRP	an average of 1 year	change of CPP
change of Hcy	an average of 1 year	change of Hcy

Trial Locations

Locations (1)

Guangdong Province Hospital of Tradtional Chinese Medicine; 🇨🇳 Guangzhou, Guangdong, China