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临床试验/NCT03935373
NCT03935373Unknown不适用

Using the DNA Exome Sequencing Tools to Explore the Association Among Gene Sequence, TCM Pattern, TCM Tongue Diagnosis and TCM Pulse Diagnosis for Sjögren's Syndrome

Taipei Veterans General Hospital, Taiwan1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年4月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
Immunity-related gene expression

研究概览

简要总结

To explore the association among gene, TCM pattern, TCM tongue diagnosis and TCM pulse diagnosis with the DNA Exome sequencing tools for Sjögren's syndrome

详细描述

Objective: To explore the association among gene, TCM pattern, TCM tongue diagnosis and TCM pulse diagnosis with the DNA Exome sequencing tools for Sjögren's syndrome

Method:

This study wants to establish the reference value of DNA gene variants of healthy control for comparing with the Sjögren's syndrome subjects. And the investigators want to use the DNA Exome sequencing tools, proteomics and oral microbiome to explore the association of gene expression between at least 30 Sjögren's syndrome subjects and at least 10 healthy control subjects. Finally, the investigators also analyze the association among gene expression, proteomics and oral microbiome, TCM pattern, TCM tongue diagnosis, TCM pulse diagnosis, and heart rate variability (HRV) for this purpose.

Expected Results:

  1. To evaluate the difference among TCM pattern, TCM tongue diagnosis, TCM pulse diagnosis, and HRV for the Sjögren's syndrome and healthy control.
  2. To evaluate the immunity-related gene expression for the Sjögren's syndrome and healthy control.
  3. To evaluate the proteomics for the Sjögren's syndrome and healthy control.
  4. To evaluate the oral microbiome for the Sjögren's syndrome and healthy control.
  5. To evaluate the association among the immunity-related gene expression, SSA, SSB and RF.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

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

入选标准

  • (1) primary or secondary SS
  • (2) aged between 20 and 75 years
  • (3) fulfilled the 2002 American-European Consensus Criteria for SS (AECG)
  • (4) had no abnormal findings of immune, liver, kidney, or blood function evaluations.

排除标准

  • (1)a history of alcohol abuse, diabetes mellitus, or major life-threatening condition
  • (2) pregnancy or breastfeeding
  • (3) steroid pulse therapy within three months prior to the commencement of our study.
  • Health Subjects
  • Inclusion Criteria:
  • (1) aged 20 and 75 years
  • (2) had no chronic inflammatory illness.
  • Exclusion Criteria:
  • (1) a history of alcohol abuse, diabetes mellitus, or major life-threatening condition
  • (2) pregnancy or breastfeeding
  • (3) abnormal findings of immune, liver, kidney, or blood function evaluations
  • (4) total sleeping time insufficiency less than 6 hours before one day of enrollment
  • (5) ever took the conventional medicine or hormone within one month
  • (6) ever encountered the acute illness, allergy reaction, immune, or rheumatic disease within one month.

结局指标

主要结局

Immunity-related gene expression

时间窗: One year

To evaluate the immunity-related gene expression for the Sjögren's syndrome and healthy control. DNA exome combine the GATK (Genome Analysis Toolkit) is a tool for detecting the ratio of immunity-related gene expression.

Heart rate variability (HRV)

时间窗: One year

To evaluate the difference of Heart rate variability (HRV) between Sjögren's syndrome and healthy control. HRV is a tool for detecting the ratio between High-frequency (HF) activity and low-frequency (LF) activity.

Immunity-related microbiome expression

时间窗: One year

To evaluate the oral microbiome for the Sjögren's syndrome and healthy control. Oral microbiome is a tool for detecting the ratio of immunity-related microbiome expression.

TCM tongue diagnosis

时间窗: One year

To evaluate the difference of TCM tongue diagnosis between Sjögren's syndrome and healthy control. TCM tongue diagnosis is a tool for detecting tongue expression.

Immunity-related proteomics expression

时间窗: One year

To evaluate the proteomics for the Sjögren's syndrome and healthy control. Proteomics is a tool for detecting the ratio of immunity-related proteomics expression.

TCM pulse diagnosis

时间窗: One year

To evaluate the difference of TCM pulse diagnosis between Sjögren's syndrome and healthy control. TCM pulse diagnosis is a tool for detecting pulse of radial artery.

TCM pattern

时间窗: One year

To evaluate the difference of TCM pattern between Sjögren's syndrome and healthy control. TCM pattern is a tool for detecting the constitution.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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