Multi-center Randomized Controlled Clinical Study of Shenling Baishu Granule to Prevent the Recurrence of Low-risk Colorectal Adenoma
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 624
- 试验地点
- 1
- 主要终点
- Incidence of metachronous low-risk adenomas within 3 years after first dose
研究概览
简要总结
- Complete a large-sample, multicenter, randomized blank-controlled clinical trial to evaluate Shenling Baizhu Granules for the prevention of colorectal adenoma recurrence.
- Generate high-level, internationally recognized clinical evidence to support the development of clinical practice guidelines for the prevention and treatment of colorectal adenoma using traditional Chinese medicine, and to strengthen the recommendation level of Shenling Baizhu Granules in clinical guidelines.
- Define the clinical characteristics of patient subgroups most likely to benefit from Shenling Baizhu Granules for preventing colorectal adenoma recurrence.
详细描述
This study is designed within the traditional Chinese medicine (TCM) framework for colorectal adenoma and will be conducted as a prospective, multicenter, open-label, randomized, blank-controlled clinical trial. All participants will undergo standard endoscopic minimally invasive treatment and receive health education. In addition to these measures, participants in the intervention group will receive Shenling Baizhu Granules (6 g per dose, three times daily). The intervention will be initiated within 3 months after the baseline treatment/health education and continued for 6 consecutive months. Participants in the control group will not receive Shenling Baizhu Granules.
At baseline, demographic characteristics, adenoma-related information, and TCM syndrome assessment scores will be collected. Follow-up will be conducted every 6 months during the first 2 years, and once in the third year. Biospecimens and TCM assessments will be collected at three time points: (i) baseline, (ii) 6 months after initiation of medication in Year 1, and (iii) after colonoscopic reassessment in Year 3. At each time point, plasma, stool, tongue coating, saliva, and tissue samples, as well as the TCM syndrome assessment questionnaire, will be obtained.
To characterize the subpopulation most likely to benefit from Shenling Baizhu Granules in preventing colorectal adenoma recurrence, we will integrate and analyze: baseline clinical factors (e.g., age, sex, family history of cancer, smoking and alcohol use); conventional medical features (e.g., adenoma location, number, size, histopathological type, and concomitant medications); TCM-related features (e.g., evolution of TCM syndrome patterns and objective tongue/pulse parameters); and biological profiles (e.g., cytokines, proteins, metabolites, and gut microbiota). Common characteristics of the beneficial population will then be summarized based on these multidimensional data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets the diagnostic criteria for low-risk colorectal adenoma.
- •Has undergone a colonoscopy of adequate quality (adequate bowel preparation, cecal intubation achieved, and withdrawal time ≥6 minutes) and received endoscopic minimally invasive polypectomy.
- •Within 3 months after adenoma resection.
- •18-70 years of age; any sex.
- •Willing to participate and has voluntarily provided written informed consent.
排除标准
- •Incomplete adenoma resection.
- •Long-term use of aspirin, folic acid, calcium supplements, vitamin D, or similar agents.
- •Known hereditary polyposis syndromes (e.g., familial adenomatous polyposis) or hereditary colorectal cancer syndromes (e.g., Lynch syndrome/hereditary nonpolyposis colorectal cancer).
- •Colonoscopy findings strongly suggestive of inflammatory bowel disease.
- •History of malignancy within the past 5 years.
- •Pregnant or breastfeeding women, or participants with pregnancy potential who are planning pregnancy.
- •Severe cardiovascular or cerebrovascular disease, hepatic or renal insufficiency, or diabetes mellitus.
- •Severe psychiatric disorders that would preclude cooperation with colonoscopy procedures.
- •Current condition preventing oral administration of the study drug (e.g., dysphagia, chronic diarrhea, intestinal obstruction).
- •Participation in another clinical study within the past 3 months or current participation in another clinical study.
- •Any other condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.
研究组 & 干预措施
Experimental Group (Shenling Baizhu Granules)
Participants will take Shenling Baizhu granules (6 g, three times daily) for 6 months, started within 3 months after standard endoscopic treatment, in addition to basic health education.
干预措施: Shenling Baizhu granules (TCM patent medicine) (Drug)
Control Group (No intervention)
Participants will receive only basic health education without taking Shenling Baizhu granules.
结局指标
主要结局
Incidence of metachronous low-risk adenomas within 3 years after first dose
时间窗: At 3 years after enrollment
The incidence of metachronous low-risk adenomas will be calculated for each group as the number of participants with metachronous low-risk adenomas detected on surveillance colonoscopy within 3 years of enrollment divided by the total number of participants in that group.
次要结局
- Colorectal adenoma progression rate(At 3 years after enrollment)
- TCM syndrome score(At baseline, 6 months, and 36 months)
研究者
Xiaobo Li
Principal Investigator
Shanghai Jiao Tong University School of Medicine