Clinical Trial: System Biology of Spleen Deficiency Syndrome

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

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

Brief Summary: 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.

Detailed Summary:
Sponsor: Beijing University of Chinese Medicine

Current Primary Outcome:

  • Examination of the stomach with an endoscope. [ Time Frame: at the beginning of the enrollment ]
    Endoscopic diagnosis standard of chronic gastritis according to Chinese Society of Digestive Endoscopy.
  • Pathological biopsy of gastric mucosa. [ Time Frame: 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
  • Detection of helicobacter pylori by Urea Breath Test(UBT) [ Time Frame: at the beginning of the enrollment ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Beijing University of Chinese Medicine

Dates:
Date Received: September 17, 2016
Date Started: September 2016
Date Completion: December 2019
Last Updated: September 23, 2016
Last Verified: September 2016