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临床试验/NCT03711435
NCT03711435已完成不适用

Study on TCM Syndrome Classification of Idiopathic Pulmonary Fibrosis Based on Metabolomics

Xuzhou Traditional Chinese Medicine Hospital1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2018年10月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
75
试验地点
1
主要终点
biomarkers detected in metabolites

研究概览

简要总结

The pathogenesis of idiopathic pulmonary interstitial fibrosis is complex, and there is no specific biomarkers, the treatment effect is not such useful. Currently, it is discovered that Chinese medicine treatment may be effective. The investigators select patients with idiopathic pulmonary interstitial fibrosis and healthy controls, use metabolomics to study the biological characteristics of idiopathic pulmonary interstitial fibrosis, screen biomarkers of IPF, and label different TCM syndromes of IPF, explore the biological nature of IPF TCM syndromes, find the biological changes that occur during the development and progression of IPF and explore the metabolite marker clusters of IPF. Furthermore, the results of this study may find its diagnostic significance for IPF and Looking for potential targets for future treatment of IPF.

研究设计

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

入排标准

年龄范围
50 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Case group inclusion criteria
  • According to the diagnostic criteria published in 2015, the New Guidelines for the Diagnosis and Treatment of Idiopathic Pulmonary Fibrosis, jointly developed by the American Thoracic Society, the European Respiratory Society, the Japanese Respiratory Society, and the Latin American Thoracic Society;
  • aged 50 to 85 years old;
  • Control group inclusion criteria:
  • Health people match on the age (±3 years old) and gender with case group with 1:1 rate at the same time.

排除标准

  • Case group exclusion criteria:
  • Those with severe heart, liver, kidney and other organ dysfunction or suffering from blood diseases;
  • with malignant tumors;
  • Severely infected people;
  • Pregnant and lactating women;
  • mental illness, serious obstacles and those who are unwilling to cooperate;
  • Control group exclusion criteria:
  • Those with severe heart, liver, kidney and other organ dysfunction or blood disease;
  • With malignant tumors;
  • Chest X-ray or chest low-dose CT suggesting intra-pulmonary interstitial fibrosis;
  • With chronic pulmonary diseases such as pulmonary interstitial disease, chronic obstructive pulmonary disease, and bronchial asthma;
  • With connective tissue disease and those with a history of exposure to occupational diseases;
  • Mental illness, serious obstacles and unwilling to cooperate.

结局指标

主要结局

biomarkers detected in metabolites

时间窗: 1 year

Metabolomics of serum based on mass spectrometry.It is non-targeted metabolomics.The study is to find the target metabolite to distinguish IPF.

次要结局

  • Pulmonary function Pulmonary function(1 year)
  • High-resolution chest CT total score (CT-Tot)(1 year)
  • Six Minute Walk Test(6MWT)(1 year)
  • St. George's Respiratory Questionnaire(1 year)

研究者

发起方
Xuzhou Traditional Chinese Medicine Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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