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The Dampness Syndrome of Chinese Medicine Cohort Study

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05315895
Acronym
DACOS
Enrollment
100000
Registered
2022-04-07
Start date
2022-06-06
Completion date
2028-03-30
Last updated
2022-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Dampness Syndrome, multi-center study, prospective cohort study

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.

Interventions

OTHERnatural 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.

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
35 Years to 79 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
emerging diseasesthrough study completion, an average of 1 yearThis 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

MeasureTime frameDescription
European Quality of Life 5-dimensional questionnaire (EQ-5D-5L)through study completion, an average of 1 yearThe 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 yearMMSE 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 questionnairethrough study completion, an average of 1 yearDemographic characteristic, life style. disease history, allergies will be involoved.
change of the blood routine resultsthrough study completion, an average of 1 yearWBC, RBC, PLT , HB, NEUT% and LYM% will be tested and recorded. Above or below each mormal value will be considered as abnormal.
urine routinethrough study completion, an average of 1 yearurinary 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 routinethrough study completion, an average of 1 yearcells in faeces will be tested such as RBC and WBC. Negative occult blood(FOB) is difined normal.
change of hepatic functionan average of 1 yearThe 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 functionan average of 1 yearThe 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.
Montreal Cognitive Assessment(MoCA)through study completion, an average of 1 yearMoCA 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
change of Hcyan average of 1 yearchange of Hcy
change of thyroid functionan average of 1 yearchange of TSH ,FT3, FT4
change of Vit B12 and folic acidan average of 1 yearchange of Vit B12
change of coagulation functionan average of 1 yearchange of PT, INR,TT,APTT,FIB
change of abdominal ultrasoundan average of 1 yearchange of abdominal ultrasound
change of gynecologic ultrasoundan average of 1 yearchange of gynecologic ultrasound
change of ECGan average of 1 yearThe researchers will check the change of P, QRS and ST segments separately in electrocardiogram.
change of brain MRIan average of 1 yearchange of brain MRI. The investigators will focus on the change of hippocampal volume and the spacing of temporal sulcus gyrus.
change of CRPan average of 1 yearchange of CPP

Countries

China

Contacts

Primary ContactJianwen Guo, MD
1308251832@qq.com+86-13724899379
Backup ContactBin Zhang, PhD
dochedy@163.com+86 18511308217

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026