Using the Objective Measurement Methods to Evaluate the Association With TCM Pattern and TCM Tongue Diagnosis for Autoimmune Disease and Dry Eye Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,800
- 试验地点
- 1
- 主要终点
- OSDI(Ocular Surface Disease Index)
研究概览
简要总结
To explore the association with TCM pattern and TCM tongue diagnosis for Autoimmune disease and Dry eye syndrome.
详细描述
Objective: To explore the association with TCM pattern and TCM tongue diagnosis for Autoimmune disease and Dry eye syndrome.
Method:
This study wants to include the 1000 Autoimmune disease (AID) subjects as 800 Sjögren's syndrome (SJS) and 200 Systemic lupus erythematosus (SLE) for comparing with the 500 Dry eye syndrome (DES) subjects. AID and DES subjects will be enrolled to evaluate at V1 Baseline and follow-up for 6 times evaluation with one month interval during one year. And the non-AID-non-DES healthy control subjects will be also included in our study for comparison with the dry eye syndrome and healthy control. This study want to use objective measurement and questionnaires as TCM pattern, OSDI, ESSPRI, SF-36, Schirmer's test, TCM heart rate variability, and TCM tongue diagnosis to differentiate AID, DES and healthy control.
Expected Results:
- To evaluate the difference among TCM pattern, OSDI, ESSPRI, SF-36, Schirmer's test, TCM heart rate variability, and TCM tongue diagnosis to differentiate between AID and DES.
- To evaluate the difference among TCM pattern and TCM tongue diagnosis among the AID groups, DES group, and healthy control.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged between 20 and 75 years
- •fulfilled the 2002 American-European Consensus Criteria for SS (AECG)
排除标准
- •Systemic lupus erythematosus
- •Inclusion Criteria:
- •aged between 20 and 75 years
- •fulfilled the 1982 and 1997 ACR revised Systemic lupus erythematosus criteria
- •Exclusion Criteria: NA
- •Dry eye syndrome
- •Inclusion Criteria:
- •aged between 20 and 75 years
- •Schirmer's test less than 10 mm/5 min
- •Exclusion Criteria: NA
- •non AIDDES Healthy Controls
- •Inclusion Criteria:
- •aged between 20 and 75 years
- •without any Chronic disease
- •Exclusion Criteria: any Sjögren's syndrome, Systemic lupus erythematosus, or Dry eye syndrome.
结局指标
主要结局
OSDI(Ocular Surface Disease Index)
时间窗: One year
OSDI is a tool to rate the severity of dry eye disease among the Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE), and Dry eye syndrome (DES).
ESSPRI(EULAR Sjögren's Syndrome Patient Reported Index)
时间窗: One year
ESSPRI is a tool for evaluating the symptoms of SJS among the Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE), and Dry eye syndrome (DES).
TCM pattern
时间窗: One year
TCM pattern is a tool for detecting the constitution among the Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE), Dry eye syndrome (DES), and healthy control.
TCM tongue diagnosis
时间窗: One year
TCM tongue diagnosis is a tool for detecting tongue expression among the Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE), Dry eye syndrome (DES), and healthy control.
Heart rate variability (HRV)
时间窗: One year
Heart rate variability (HRV) is a tool for detecting ratio between High-frequency (HF) activity and low-frequency (LF) activity among the Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE),and Dry eye syndrome (DES).
SF-36(36-Item Short Form Survey )
时间窗: One year
SF-36 is a tool for evaluating Health-Related Quality of Life among the Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE), and Dry eye syndrome (DES).
Schirmer's test
时间窗: One year
Schirmer's test is a tool for evaluating aqueous tear production among the Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE), and Dry eye syndrome (DES).
次要结局
未报告次要终点