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临床试验/NCT05315895
NCT05315895招募中不适用

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

Guangzhou University of Traditional Chinese Medicine1 个研究点 分布在 1 个国家目标入组 100,000 人开始时间: 2022年6月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100,000
试验地点
1
主要终点
emerging diseases

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
35 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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;

排除标准

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

结局指标

主要结局

emerging diseases

时间窗: 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.

次要结局

  • change of faeces routine(through study completion, an average of 1 year)
  • change of Vit B12 and folic acid(an average of 1 year)
  • change of coagulation function(an average of 1 year)
  • change of the blood routine results(through study completion, an average of 1 year)
  • change of thyroid function(an average of 1 year)
  • change of brain MRI(an average of 1 year)
  • European Quality of Life 5-dimensional questionnaire (EQ-5D-5L)(through study completion, an average of 1 year)
  • interview questionnaire(through study completion, an average of 1 year)
  • urine routine(through study completion, an average of 1 year)
  • change of abdominal ultrasound(an average of 1 year)
  • change of ECG(an average of 1 year)
  • Montreal Cognitive Assessment(MoCA)(through study completion, an average of 1 year)
  • Mini-Mental State Exam (MMSE)(through study completion, an average of 1 year)
  • change of renal function(an average of 1 year)
  • change of gynecologic ultrasound(an average of 1 year)
  • change of hepatic function(an average of 1 year)
  • change of CRP(an average of 1 year)
  • change of Hcy(an average of 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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