- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02915393
System Biology of Spleen Deficiency Syndrome (SBSDS)
September 23, 2016 updated by: Anlong Xu, Beijing University of Chinese Medicine
System Biology Research of Spleen Qi Deficiency Associated "Qi Deficiency Constitution-Disease"
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.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
90
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
A total of 90 cases will be gathered between August, 2016 and September, 2017.
All the cases include: ①10 healthy volunteers in Beijing with balanced constitution, 10 with Qi Deficient Constitution (Spleen-qi Deficiency Syndrome) and 10 with Damp-heat Constitution.
②Patients in Dongfang Hospital diagnosed as chronic superficial gastritis,chronic atrophic gastritis or gastric cancer, 20 for each disease and half of each with Spleen-qi Deficiency Syndrome, half with Spleen Damp-heat Syndrome.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
---|
Healthy Volunteers (BC)
Healthy Volunteers with Balanced Constitution(n=10).
|
Healthy Volunteers(QC)
Healthy Volunteers with Qi Deficiency Constitution(n=10).
|
Healthy Volunteers(DC)
Healthy Volunteers with Damp-heat Constitution(n=10).
|
Superficial Gastritis(SDS)
Superficial Gastritis with Spleen-qi Deficiency Syndrome(n=10).
|
Superficial Gastritis(DS)
Superficial Gastritis with Damp-heat Syndrome(n=10).
|
Atrophic Gastritis(SDS)
Atrophic Gastritis with Spleen-qi Deficiency Syndrome(n=10).
|
Atrophic Gastritis(DS)
Atrophic Gastritis with Damp-heat Syndrome(n=10).
|
Gastric Cancer(SDS)
Gastric Cancer with Spleen-qi Deficiency Syndrome(n=10).
|
Gastric Cancer(DS)
Gastric Cancer with Damp-heat Syndrome(n=10).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
at the beginning of the enrollment
|
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
|
at the beginning of the enrollment
|
Detection of helicobacter pylori by Urea Breath Test(UBT)
Time Frame: at the beginning of the enrollment
|
at the beginning of the enrollment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Analysis of gastric mucosa/venous blood/urine by system biology techniques
Time Frame: Three measurements within 1 year
|
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
|
at the beginning of the enrollment
|
TCM syndrome type diagnosed by two professional TCM doctors
Time Frame: at the beginning of the enrollment
|
at the beginning of the enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Anlong Xu, Beijing University of Chinese Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2016
Primary Completion (Anticipated)
September 1, 2017
Study Completion (Anticipated)
December 1, 2019
Study Registration Dates
First Submitted
September 17, 2016
First Submitted That Met QC Criteria
September 23, 2016
First Posted (Estimate)
September 27, 2016
Study Record Updates
Last Update Posted (Estimate)
September 27, 2016
Last Update Submitted That Met QC Criteria
September 23, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 81430099
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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