Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT02915393
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02915393
Study Brief:
Protocol Section:
NCT02915393