Chronic DiseaseDACOSNCT05315895
The Dampness Syndrome of Chinese Medicine Cohort Study
An observational study of Chronic Disease and Cancer, run by Guangzhou University of Traditional Chinese Medicine at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 35 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Disease, Cancer, Dementia Alzheimers
- What is being tested?
- natural aging process
- How many people
- 100,000 participants
- Where
- 1 siteChina
- Study dates
- 6 Jun 2022to 30 Mar 2028
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: general population in a specific area and specifc time range. Such as civil servants of Guangdong Province. Medical workers in Xinjiang.
Who may be able to join
- 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;
Who cannot join
- Residents who reject collaboration;
- Residents who allow no follow-up visits.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangdong Province Hospital of Tradtional Chinese Medicine
Guangzhou, Guangdong, 510120
jianwen Guo, Dr, 020-81887233 ext. 34530, jianwen_guo@msn.com
Jianwen Guo, MD
About this study
Official title: 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.
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.
- Conditions
- Chronic Disease, Cancer, Dementia Alzheimers, Metabolic Disease, Aging, Alzheimer Disease, Early Onset
- Being tested
- natural aging process
- Keywords
- Dampness Syndrome, multi-center study, prospective cohort study
- Medical subject headings
- Chronic Disease, Neoplasms, Alzheimer Disease, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
natural aging processOther
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.
| Study group | Role | What they receive |
|---|---|---|
| general population | general population in a specific area and specifc time range. Receives: Other: natural aging process |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 1 year
Secondary outcomes (18)
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
Measured: 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.
Measured: 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.
Measured: through study completion, an average of 1 year
interview questionnaire
Demographic characteristic, life style. disease history, allergies will be involoved.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: an average of 1 year
change of CRP
change of CPP
Measured: an average of 1 year
change of Hcy
change of Hcy
Measured: an average of 1 year
change of thyroid function
change of TSH ,FT3, FT4
Measured: an average of 1 year
change of Vit B12 and folic acid
change of Vit B12
Measured: an average of 1 year
change of coagulation function
change of PT, INR,TT,APTT，FIB
Measured: an average of 1 year
change of abdominal ultrasound
change of abdominal ultrasound
Measured: an average of 1 year
change of gynecologic ultrasound
change of gynecologic ultrasound
Measured: an average of 1 year
change of ECG
The researchers will check the change of P, QRS and ST segments separately in electrocardiogram.
Measured: 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.
Measured: an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start6 Jun 2022
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Guangzhou University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- State Key Laboratory of Dampness Syndrome of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05315895
- Sponsor's protocol ID
- SZ2021ZZ06
- Acronym
- DACOS
- Status last verified
- Nov 2022
- First submitted
- 11 Mar 2022
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Publications
Li M, Liu N, Jiang G, Zeng H, Guo J, Wu D, Zhou H, Wen Z, Zhou L. Health-related quality of life in populations with diabetes, prediabetes, and normal glycemic levels in Guangzhou, China: a cross-sectional study. Front Endocrinol (Lausanne). 2025 May 23;16:1518204. doi: 10.3389/fendo.2025.1518204. eCollection 2025.
PubMed 40487765
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Prospective Cohort Study of Dampness Syndrome in China
- ClinicalTrials.gov ID
- NCT05315895
- Acronym / sponsor ID
- DACOS / SZ2021ZZ06
- Conditions
- Chronic Disease, Cancer, Dementia Alzheimers, Metabolic Disease, Aging, Alzheimer Disease, Early Onset
- Keywords
- Dampness Syndrome, multi-center study, prospective cohort study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Guangzhou University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- State Key Laboratory of Dampness Syndrome of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Mar 2028 (estimated)
- First posted
- 7 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| general population | – | Other: natural aging processgeneral population in a specific area and specifc time range. |
Who may qualify
- Ages
- 35 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- general population in a specific area and specifc time range. Such as civil servants of Guangdong Province. Medical workers in Xinjiang.
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (2 listed)
- Residents who reject collaboration;
- Residents who allow no follow-up visits.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| natural aging processTo 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. | Other | general population |
Primary outcome
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.
18 secondary outcomes
Montreal Cognitive Assessment(MoCA)
Time frame: through study completion, an average of 1 year
European Quality of Life 5-dimensional questionnaire (EQ-5D-5L)
Time frame: through study completion, an average of 1 year
Mini-Mental State Exam (MMSE)
Time frame: through study completion, an average of 1 year
interview questionnaire
Time frame: through study completion, an average of 1 year
change of the blood routine results
Time frame: through study completion, an average of 1 year
urine routine
Time frame: through study completion, an average of 1 year
change of faeces routine
Time frame: through study completion, an average of 1 year
change of hepatic function
Time frame: an average of 1 year
change of renal function
Time frame: an average of 1 year
change of CRP
Time frame: an average of 1 year
change of Hcy
Time frame: an average of 1 year
change of thyroid function
Time frame: an average of 1 year
change of Vit B12 and folic acid
Time frame: an average of 1 year
change of coagulation function
Time frame: an average of 1 year
change of abdominal ultrasound
Time frame: an average of 1 year
change of gynecologic ultrasound
Time frame: an average of 1 year
change of ECG
Time frame: an average of 1 year
change of brain MRI
Time frame: an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- Derived from this study: PubMed 40487765Li M, Liu N, Jiang G, Zeng H, Guo J, Wu D, Zhou H, Wen Z, Zhou L. Health-related quality of life in populations with diabetes, prediabetes, and normal glycemic levels in Guangzhou, China: a cross-sectional study. Front Endocrinol (Lausanne). 2025 May 23;16:1518204. doi: 10.3389/fendo.2025.1518204. eCollection 2025.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Disease and Cancer, run by Guangzhou University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianwen Guo, MD (+86-13724899379, 1308251832@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
emerging diseases (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05315895, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022.