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NCT Number: NCT05315895

The Dampness Syndrome of Chinese Medicine Cohort Study

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.

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Key information

Conditions

Chronic Disease Aging Alzheimer Disease Alzheimer Disease, Early Onset Brain Diseases Cancer Central Nervous System Diseases Dementia Dementia Alzheimers Disease Attributes Mental Disorders Metabolic Disease Metabolic Diseases Neoplasms Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tauopathies

Age range

35 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Guangdong Province Hospital of Tradtional Chinese Medicine

Guangzhou, Guangdong, 510120, China

Location status: Recruiting

Location contact

Jianwen Guo, MD

PRINCIPAL_INVESTIGATOR

jianwen Guo, Dr

CONTACT

[email protected]

020-81887233 ext. 34530

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

natural aging process

Other

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.

Primary outcomes

  1. emerging diseases

    Time frame: 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 outcomes

  1. Montreal Cognitive Assessment(MoCA)

    Time frame: 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

  2. European Quality of Life 5-dimensional questionnaire (EQ-5D-5L)

    Time frame: 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.

  3. Mini-Mental State Exam (MMSE)

    Time frame: 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.

  4. interview questionnaire

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

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

  5. change of the blood routine results

    Time frame: 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.

  6. urine routine

    Time frame: 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.

  7. change of faeces routine

    Time frame: 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.

  8. change of hepatic function

    Time frame: 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.

  9. change of renal function

    Time frame: 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.

  10. change of CRP

    Time frame: an average of 1 year

    change of CPP

  11. change of Hcy

    Time frame: an average of 1 year

    change of Hcy

  12. change of thyroid function

    Time frame: an average of 1 year

    change of TSH ,FT3, FT4

  13. change of Vit B12 and folic acid

    Time frame: an average of 1 year

    change of Vit B12

  14. change of coagulation function

    Time frame: an average of 1 year

    change of PT, INR,TT,APTT，FIB

  15. change of abdominal ultrasound

    Time frame: an average of 1 year

    change of abdominal ultrasound

  16. change of gynecologic ultrasound

    Time frame: an average of 1 year

    change of gynecologic ultrasound

  17. change of ECG

    Time frame: an average of 1 year

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

  18. change of brain MRI

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bin Zhang, PhD

CONTACT

[email protected]

+86 18511308217

Jianwen Guo, MD

CONTACT

[email protected]

+86-13724899379

Sponsors and collaborators

Lead sponsor

Guangzhou University of Traditional Chinese Medicine

Other

Collaborators

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

Registry information

Official study title

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

Acronym: DACOS

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Apr 7, 2022
Registry last updated
Nov 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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