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临床试验/NCT02915393
NCT02915393Unknown不适用

System Biology Research of Spleen Qi Deficiency Associated "Qi Deficiency Constitution-Disease"

Beijing University of Chinese Medicine0 个研究点目标入组 90 人开始时间: 2016年9月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
90
主要终点
Detection of helicobacter pylori by Urea Breath Test(UBT)

研究概览

简要总结

Spleen Deficiency Syndrome(SDS)is a widely researched issue, but due to the limitations of the research methods, the scientific mechanism of SDS is biased and not comprehensive. SDS would be researched in this project deeply and systematically with modern life-scientific methods. Based on the previous work, the participants, with SDS, suffering from Qi deficiency syndrome--chronic superficial gastritis--chronic atrophic gastritis--gastric cancer would be included, and the corresponding research would be conducted at the molecular-cell-gastric tissue level, and at the same time, systematical biological database of SDS would be built by systematical biological methods, such as pioneered SPARS sequencing technology created in our research group, proteomics and metabonomics. Under the above work, the investigators would conduct data mining and molecular network analysis, and then verify the key functions. By analyzing the systematical biological features of syndrome and its relationships with constitution and disease, this study would provide a new basis for objective reality of syndrome, and also offer a crucial premise of revealing biological basis for syndrome correctly, which is of important theoretical and practical significance.

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
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged between 18 and 65 years.
  • No apparent abnormality in the routine blood test, urinalysis, routine stool & fecal occult blood test, biochemical test, chest radiograph and electrocardiogram(ECG).
  • The endoscopic diagnoses of chronic superficial gastritis, chronic atrophic gastritis and gastric cancer conform to the corresponding pathological diagnoses
  • TCM diagnoses of Spleen-qi Deficiency Syndrome or Spleen Damp-heat Syndrome.
  • Voluntary participation.
  • Having given written informed consent.

排除标准

  • Gastropathy with special causes, such as acute gastritis, gastrinoma, chronic gastritis resulting from special causes (like granulomatous gastritis, lymphocytic gastritis, eosinophilic gastritis, gastritis after gastric operation) peptic ulcer, other malignant tumors of stomach (like gastric lymphoma, gastri stromal tumor, carcinoid tumor, malignant hemangioma, squamous-cell carcinoma, primary gastric choriocarcinoma and metastatic gastric tumor), benign gastritic tumors that originate from epithelium or submucosa (epithelial tumors like adenomatous polyps and hyperplastic polyps, stromal tumors like benign stromal tumor, neuronal tumor and pseudolymphoma).
  • Combined with other digestive diseases (like gastroesophageal reflux, esophageal varices, acute and chronic hepatitis and cirrhosis arising from various causes, acute/chronic pancreatitis and acute/chronic cholecystitis).
  • Combined with other severe systemic diseases such as respiratory failure, severe cardiovascular and cerebrovascular, immune system, urinary and mental disorders diseases.
  • Pregnancy, or planning pregnancy during the trial or within three month period thereafter.
  • Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study.

结局指标

主要结局

Detection of helicobacter pylori by Urea Breath Test(UBT)

时间窗: at the beginning of the enrollment

Examination of the stomach with an endoscope.

时间窗: at the beginning of the enrollment

Endoscopic diagnosis standard of chronic gastritis according to Chinese Society of Digestive Endoscopy.

Pathological biopsy of gastric mucosa.

时间窗: at the beginning of the enrollment

Pathological diagnosis standard of chronic gastritis according to Chinese Society of Gastroenterology.Pathological diagnosis standard of gastric cancer according to Ministry of Health P.R.China

次要结局

  • Analysis of gastric mucosa/venous blood/urine by system biology techniques(Three measurements within 1 year)
  • Constitutional classification of TCM assessed by the Traditional Chinese Medicine Physical Constitution Scale(at the beginning of the enrollment)
  • TCM syndrome type diagnosed by two professional TCM doctors(at the beginning of the enrollment)

研究者

发起方
Beijing University of Chinese Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anlong Xu

President

Beijing University of Chinese Medicine

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