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RecruitingNCT05315895DACOSUpdated Nov 15, 2022

The Dampness Syndrome of Chinese Medicine Cohort Study

An observational study in Chronic Disease, Cancer and Dementia Alzheimers, sponsored by Guangzhou University of Traditional Chinese Medicine. Recruiting at 1 site in China. Open to participants aged 35 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-15.

Sponsored by Guangzhou University of Traditional Chinese Medicine · Observational

From the registry’s dates

  • Started Jun 2022; still recruiting 4 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100,000
Ages
35 Years to 79 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • Dampness Syndrome
  • multi-center study
  • prospective cohort study
03

In context

Alzheimer Disease

3,681 studies on the registry are indexed under Alzheimer Disease; 875 are open to participants now.

This study's planned enrollment of 100,000 is above the median of 200 across 753 observational studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Guangzhou University of Traditional Chinese Medicine is the lead sponsor of 57 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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

Exclusion Criteria:

  1. Residents who reject collaboration;
  2. Residents who allow no follow-up visits.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100,000 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • general population

    general population in a specific area and specifc time range.

    Other: natural aging process

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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: through study completion, an average of 1 year

Secondary outcomes

  1. 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

    Time frame: through study completion, an average of 1 year

  2. 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.

    Time frame: through study completion, an average of 1 year

  3. 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.

    Time frame: through study completion, an average of 1 year

  4. interview questionnaire

    Demographic characteristic, life style. disease history, allergies will be involoved.

    Time frame: through study completion, an average of 1 year

  5. 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.

    Time frame: through study completion, an average of 1 year

  6. 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.

    Time frame: through study completion, an average of 1 year

  7. change of faeces routine

    cells in faeces will be tested such as RBC and WBC. Negative occult blood(FOB) is difined normal.

    Time frame: through study completion, an average of 1 year

  8. 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.

    Time frame: an average of 1 year

  9. 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.

    Time frame: an average of 1 year

  10. change of CRP

    change of CPP

    Time frame: an average of 1 year

  11. change of Hcy

    change of Hcy

    Time frame: an average of 1 year

  12. change of thyroid function

    change of TSH ,FT3, FT4

    Time frame: an average of 1 year

  13. change of Vit B12 and folic acid

    change of Vit B12

    Time frame: an average of 1 year

  14. change of coagulation function

    change of PT, INR,TT,APTT,FIB

    Time frame: an average of 1 year

  15. change of abdominal ultrasound

    change of abdominal ultrasound

    Time frame: an average of 1 year

  16. change of gynecologic ultrasound

    change of gynecologic ultrasound

    Time frame: an average of 1 year

  17. change of ECG

    The researchers will check the change of P, QRS and ST segments separately in electrocardiogram.

    Time frame: an average of 1 year

  18. 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.

    Time frame: an average of 1 year

07

Study locations

1 of 1 sites recruiting
  • Guangdong Province Hospital of Tradtional Chinese Medicine
    Guangzhou, Guangdong 510120, China
    • jianwen Guo, Dr · Contact · jianwen_guo@msn.com · 020-81887233
    • Jianwen Guo, MD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — 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

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05315895
Lead 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
Responsible party
Sponsor
First posted
Apr 7, 2022
Start date
Jun 6, 2022
Primary completion
Dec 30, 2027 (estimated)
Completion
Mar 30, 2028 (estimated)
Last update
Nov 15, 2022

Study contacts

Jianwen Guo, MD
Contact
1308251832@qq.com
+86-13724899379
Bin Zhang, PhD
Contact
dochedy@163.com
+86 18511308217

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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