The Dampness Syndrome of Chinese Medicine Cohort Study (DACOS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Chronic Disease; Aging; Alzheimer Disease, Early Onset; Metabolic Disease; Dementia Alzheimers
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 100000

Contacts and Locations

• Study Contact: Name: Jianwen Guo, MD; Phone Number: +86-13724899379; Email: 1308251832@qq.com
• Study Contact Backup: Name: Bin Zhang, PhD; Phone Number: +86 18511308217; Email: dochedy@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • Guangdong Province Hospital of Tradtional Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2022
• Primary Completion (Anticipated): December 30, 2027
• Study Completion (Anticipated): March 30, 2028

Study Registration Dates

• First Submitted: March 11, 2022
• First Submitted That Met QC Criteria: March 30, 2022
• First Posted (Actual): April 7, 2022

Study Record Updates

• Last Update Posted (Actual): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 14, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: prospective cohort study; multi-center study; Dampness Syndrome
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Disease Attributes; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease; Chronic Disease; Metabolic Diseases
• Other Study ID Numbers: SZ2021ZZ06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: If you need to access or use the population information database and biological sample database, you must go through strict application and approval processes at first
• IPD Sharing Time Frame: After half year of the baseline and follow-ups data completing.
• IPD Sharing Access Criteria: A professional qualification panel determines whether the visitor is qualified to view and use the repository.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No