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System Biology of Spleen Deficiency Syndrome

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02915393
Acronym
SBSDS
Enrollment
90
Registered
2016-09-27
Start date
2016-09-30
Completion date
2019-12-31
Last updated
2016-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer, Gastritis, Atrophic

Keywords

Chronic Gastritis, Qi Deficiency Constitution, Next Generation Sequencing, Proteomics, Metabonomics

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.

Interventions

None listed

Sponsors

Beijing University of Chinese Medicine
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Examination of the stomach with an endoscope.at the beginning of the enrollmentEndoscopic diagnosis standard of chronic gastritis according to Chinese Society of Digestive Endoscopy.
Pathological biopsy of gastric mucosa.at the beginning of the enrollmentPathological 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)at the beginning of the enrollment

Secondary

MeasureTime frame
Analysis of gastric mucosa/venous blood/urine by system biology techniquesThree measurements within 1 year
Constitutional classification of TCM assessed by the Traditional Chinese Medicine Physical Constitution Scaleat the beginning of the enrollment
TCM syndrome type diagnosed by two professional TCM doctorsat the beginning of the enrollment

Contacts

Primary ContactXiaopu Sang
sxp@bucm.edu.cn+86 15101021386
Backup ContactLeiming You
youleiming@bucm.edu.cn

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026