Clinical trial NCT05315895: The Dampness Syndrome of Chinese Medicine Cohort Study
Official title: A Multi-Center Prospective Cohort Study of Dampness Syndrome in China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Disease
Cancer
Dementia Alzheimers
Metabolic Disease
Aging
Alzheimer Disease, Early Onset
Keywords: Dampness Syndrome
multi-center study
prospective cohort study
Lead sponsor: Guangzhou University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: State Key Laboratory of Dampness Syndrome of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine
First posted: 2022-04-07
Enrollment: 100000
Sex: ALL
Minimum age (years): 35
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: emerging diseases
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Montreal Cognitive Assessment(MoCA)
timeFrame: through study completion, an average of 1 year
measure: European Quality of Life 5-dimensional questionnaire (EQ-5D-5L)
timeFrame: through study completion, an average of 1 year
measure: Mini-Mental State Exam (MMSE)
timeFrame: through study completion, an average of 1 year
measure: interview questionnaire
timeFrame: through study completion, an average of 1 year
measure: change of the blood routine results
timeFrame: through study completion, an average of 1 year
measure: urine routine
timeFrame: through study completion, an average of 1 year
measure: change of faeces routine
timeFrame: through study completion, an average of 1 year
measure: change of hepatic function
timeFrame: an average of 1 year
measure: change of renal function
timeFrame: an average of 1 year
measure: change of CRP
timeFrame: an average of 1 year
measure: change of Hcy
timeFrame: an average of 1 year
measure: change of thyroid function
timeFrame: an average of 1 year
measure: change of Vit B12 and folic acid
timeFrame: an average of 1 year
measure: change of coagulation function
timeFrame: an average of 1 year
measure: change of abdominal ultrasound
timeFrame: an average of 1 year
measure: change of gynecologic ultrasound
timeFrame: an average of 1 year
measure: change of ECG
timeFrame: an average of 1 year
measure: change of brain MRI
timeFrame: an average of 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Province Hospital of Tradtional Chinese Medicine
state: Guangdong
Study officials:
References: