System Biology of Spleen Deficiency Syndrome

NCT ID: NCT02915393

Last Updated: 2016-09-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2019-12-31

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.

Conditions

Gastritis, Atrophic; Gastric Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Healthy Volunteers (BC)

Healthy Volunteers with Balanced Constitution(n=10).

No interventions assigned to this group

Healthy Volunteers(QC)

Healthy Volunteers with Qi Deficiency Constitution(n=10).

No interventions assigned to this group

Healthy Volunteers(DC)

Healthy Volunteers with Damp-heat Constitution(n=10).

No interventions assigned to this group

Superficial Gastritis(SDS)

Superficial Gastritis with Spleen-qi Deficiency Syndrome(n=10).

No interventions assigned to this group

Superficial Gastritis(DS)

Superficial Gastritis with Damp-heat Syndrome(n=10).

No interventions assigned to this group

Atrophic Gastritis(SDS)

Atrophic Gastritis with Spleen-qi Deficiency Syndrome(n=10).

No interventions assigned to this group

Atrophic Gastritis(DS)

Atrophic Gastritis with Damp-heat Syndrome(n=10).

No interventions assigned to this group

Gastric Cancer(SDS)

Gastric Cancer with Spleen-qi Deficiency Syndrome(n=10).

No interventions assigned to this group

Gastric Cancer(DS)

Gastric Cancer with Damp-heat Syndrome(n=10).

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beijing University of Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Anlong Xu

President

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anlong Xu

Role: PRINCIPAL_INVESTIGATOR

Beijing University of Chinese Medicine

Central Contacts

Xiaopu Sang

Role: CONTACT

sxp@bucm.edu.cn

+86 15101021386

Leiming You

Role: CONTACT

youleiming@bucm.edu.cn

References

You L, Zhang S, Li T, Sang X, Li K, Wang W, Gao X, Wu J, Huang G, Wang T, Xu A. Integrated analyses of miRNA and mRNA profiles in leukocytes and serums in traditional Chinese medicine (TCM)-defined Pi-qi-deficiency syndrome and Pi-wei damp-heat syndrome resulting from chronic atrophic gastritis. Chin Med. 2021 Jan 6;16(1):4. doi: 10.1186/s13020-020-00416-9.

Reference Type: DERIVED

PMID: 33407671 (View on PubMed)

Other Identifiers

81430099

Identifier Type: -

Identifier Source: org_study_id