An Epidemiological and Long-Term Endpoint Registry Study on Disease-Syndrome Correlation Patterns in Comorbid Population With Diabetes and Ischemic Cardio-Cerebrovascular Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 12,000
- 主要终点
- Pattern (or Syndrome) Evolution Law in Traditional Chinese Medicine (TCM)
研究概览
简要总结
Explore the characteristics of TCM syndrome elements and distribution patterns of syndrome types in comorbid populations; Screen for "high-risk syndrome patterns" and frequently co-occurring complex syndromes; Identify characteristic syndrome patterns at key stages: acute phase, recovery phase, and upon occurrence of endpoint events; Investigate the temporal evolution of TCM syndrome patterns and the disease-syndrome correlation patterns in comorbid patients.
详细描述
A registry study of 12,000 real-world patients with comorbidities is conducted to collect and investigate the epidemiological characteristics of populations with "Tang-Nao" (diabetes with cerebrovascular disease), "Tang-Xin" (diabetes with cardiovascular disease), and triple comorbidities. Through syndrome epidemiology surveys, multi-timepoint cross-sectional investigations on the TCM syndrome of "Toxin Damaging Collaterals" are performed to explore the characteristics of TCM syndrome elements and distribution patterns of syndrome types in comorbid populations, screen "high-risk syndromes" and frequently co-occurring complex syndromes, identify characteristic syndromes at acute phase, recovery phase, and upon occurrence of endpoint events, and investigate the evolution of TCM syndromes and disease-syndrome correlation patterns in comorbid patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 18 years Diagnosed with comorbidities relevant to "toxin-damaged collaterals" theory (e.g., type 2 diabetes mellitus with cardiovascular/cerebrovascular disease).
- •Voluntary participation with signed informed consent.
排除标准
- •Acute infectious diseases, malignant tumors, or autoimmune disorders. Mental illness or cognitive impairment affecting symptom assessment.
结局指标
主要结局
Pattern (or Syndrome) Evolution Law in Traditional Chinese Medicine (TCM)
时间窗: Baseline (enrollment, T0) and follow-up at 3 months (T1), 6 months (T2) with data collected through clinical visits and standardized syndrome assessment forms.
Based on the TCM theory of "toxin-damaged collaterals," this outcome measures the dynamic changes in syndrome patterns (including qi deficiency, phlegm-dampness, heat-toxin, etc.) and their transition rules in patients with comorbidities. Assessment will use a standardized "Toxin-Damaged Collaterals Syndrome Collection Form", integrating four diagnostic methods (tongue coating, pulse, symptom scores, and syndrome differentiation results) at multiple follow-up time points to quantify syndrome evolution trends.
次要结局
未报告次要终点