Research on the Biological Basis of "Disease-Syndrome-Formula" in the Critical State of "Remission-Recurrence" of Ulcerative Colitis (Joint Application A)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The recurrence rate of patients
研究概览
简要总结
This study will recruit 100 patients with ulcerative colitis in remission for a 6-month non intervention follow-up observation. During the study, their conditions will be recorded truthfully, including general information, disease-related symptoms and signs, inflammatory bowel disease questionnaire, anxiety self-assessment scale, depression self-assessment scale, etc., every month. Collect blood, urine, and stool samples from patients every month for examination. Follow up for each subject until their condition recurs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet the criteria based on the clinical characteristics of ulcerative colitis patients in the "remission recurrence" critical state, combined with clinical symptoms, are diagnosed with ulcerative colitis through imaging, endoscopy, laboratory, and histopathological examinations;
- •Patients with comprehensive laboratory testing indicators.
排除标准
- •Patients with incomplete case information records;
- •Patients who have not completed serological tests;
- •Complications including intestinal obstruction, intestinal perforation, toxic megacolon, and severe local stenosis;
- •Diagnosed or suspected patients with coexisting uncertain colitis, infectious or ischemic colitis;
- •Patients with coexisting local or systemic infections, any malignant diseases, or autoimmune diseases;
- •Merge primary diseases such as respiratory, circulatory, neurological, endocrine, and hematological disorders;
- •Individuals at risk of developing cancer;
- •regnant or lactating women.
结局指标
主要结局
The recurrence rate of patients
时间窗: The recurrence status of patients will be recorded during the 6-month follow-up period, and the recurrence rate will be calculated after all patients have completed the follow-up. It will take about 1 year to complete the entire process
The recurrence rate of 100 follow-up patients was counted at the end of the follow-up period
次要结局
未报告次要终点
研究者
Shengsheng Zhang
Principal Investigator
Beijing Hospital of Traditional Chinese Medicine