Application of Changyanning Granule in Endoscopic Resection of Colorectal Polyps
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- serum interleukin-6
研究概览
简要总结
This study aims to evaluate the efficacy of Chanyanning granules in patients undergoing endoscopic resection of colorectal polyps with a basal diameter of 5-30 mm. From one day before the procedure to five days postoperatively, patients will be administered Chanyanning granules. The study will observe intraoperative and postoperative bleeding, perforation, and digestive system-related clinical symptoms such as postoperative abdominal pain, bloating, diarrhea, constipation, hematochezia, and fatigue, as well as related inflammatory markers, to determine the therapeutic effect of Chanyanning granules.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with colorectal polyps through endoscopic examination and who received corresponding endoscopic treatments (EMR, hybrid ESD, ESD).
排除标准
- •Concurrent infectious diseases or malignant tumors; Accompanied by severe cardiopulmonary diseases (such as severe heart failure, COPD, etc.)
研究组 & 干预措施
The Changyanning group
The Changyanning group takes Changyanning granules starting from 1 day before surgery until 5 days after surgery. The granules are taken preoperatively at the same time as the first dose of laxative, and postoperatively starting after resuming an open diet.
干预措施: changyanning granules (Drug)
The control group
The control group does not use Changyanning granules.
干预措施: Placebo (Drug)
结局指标
主要结局
serum interleukin-6
时间窗: From enrollment to the end of treatment at 2 weeks
C-reactive protein
时间窗: From enrollment to the end of treatment at 2 weeks
erythrocyte sedimentation rate
时间窗: From enrollment to the end of treatment at 2 weeks
white blood cells
时间窗: From enrollment to the end of treatment at 2 weeks
The incidence of complications
时间窗: From enrollment to the end of treatment at 2 weeks
The incidence of complications (blood in stool, perforation) and postoperative discomfort symptoms (abdominal pain, abdominal distension, diarrhea, constipation, fatigue, fever, etc.) were compared between the experimental group and the control group (primary endpoints).
次要结局
- hospitalization costs(From enrollment to the end of treatment at 2 weeks)
- hospital stay(From enrollment to the end of treatment at 2 weeks)