Clinical Evidence-based Evaluation of the Efficacy of Shenbai Granules in Preventing Recurrent Colorectal Adenomas After Polypectomy and Its Therapeutic Mechanism
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Adenoma detection rate
研究概览
简要总结
This study evaluates Shenbai Granules in Prevention of Colorectal Adenomatous Polyp Recurrence After Colonoscopy.Half of participants will receive Shenbai Granules,while the other half will receive a placebo.
详细描述
There is no internationally recognized standard treatment for the prevention of recurrence of colorectal adenomatous polyps.
Based on TCM,previous studies have found that Shenbai Granules can significantly reduce the recurrence and deterioration rate of colorectal adenomatous polyps,reduce the proliferation of tumor cells and promote apoptosis of tumor cells.
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
- Double (Participant, Investigator)
盲法说明
A double-blind design is used in this study for the investigators and subjects. The blinding codes are separately sealed and stored by the independent third-party organization. Trial granules are randomly coded as subject unique identification codes, and used by each clinical site according to the assigned drug numbers and in the order of case enrollment. Clinical monitors and investigators must be blinded at all times.
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
- •meet the colorectal adenomatous polyp diagnosis.
- •polypectomy under colonoscopy;Including snare polypectomy,endoscopic mucosal resection,endoscopic submucosal dissection.
- •sign informed consent.
排除标准
- •colonoscopy was reported, but no pathological findings were found.
- •patients with hereditary polyposis.
- •there is reliable evidence that the tumor has infiltrated into the intrinsic mucosal layer,or deep infiltration under the mucosa is suspected.
- •combined with colorectal malignancy or previous history of colorectal malignancy.
- •colonoscopy highly suggests inflammatory bowel disease.
- •pregnant and lactating women.
- •women who recently have a planning pregnant programme.
- •prone to bleeding and using anticoagulants.
- •patients with severe cardiovascular,pulmonary and cerebrovascular diseases and liver and kidney dysfunction (ALT and AST are two times higher than the upper limit of normal value in the laboratory of the center;Serum creatinine and urea nitrogen are 1.5 times higher than the upper limit of the normal value in the laboratory of the center.
- •unstable vital signs.
- •suspect or have a history of alcohol or drug abuse.
- •frequent changes in the working environment or other circumstances are likely to cause loss of interview.
- •drugs (aspirin, folic acid, vitamin D, calcium) with potential to treat colorectal adenomas have been used.
- •those who are participating in other clinical trials.
研究组 & 干预措施
TCM-Shenbai Granules
Shenbai Granules: Hedyotis diffusa 10g, Sophorae flavescentis radix 4.5g, Codonopsis radix 7.5g, Atractylodis macrocephalae rhizoma 6g, Mume fructus 4.5g, Coptidis rhizoma 1.5g, Zingiberis rhizome praeparatum 3g, Coicis semen 10g.
Orally, 1 sachet once, diluted in 150-200 ml of boiling water, 2 times a day.
干预措施: Shenbai Granules (Drug)
TCM-Placebo
It contains 5% SBG content, and the remaining ingredients are flavoring agents, starch and coloring agents. It is the same with SBG in appearance, smell and dosage form.
Orally, 1 sachet once, diluted in 150-200 ml of boiling water, 2 times a day.
干预措施: Shenbai Granules (Drug)
结局指标
主要结局
Adenoma detection rate
时间窗: 2 years
The ratio of the number of patients with new adenoma detected by colonoscopy to the total number of cases in this group during follow-up.
次要结局
- The detection rate of sessile serrated lesions(2 years)
- The detection rate of any polypoid lesions(2 years)
- The detection rate of high-risk adenomas(2 years)