A Randomized Clinical Trial of Shenbai Granules in Reducing Recurrence of Colorectal Adenoma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Evidence-based Evaluation of the Efficacy of Shenbai Granules in Preventing Recurrent Colorectal Adenomas After Polypectomy and Its Therapeutic Mechanism

Conditions
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Gastroenterology

Intervention / Treatment
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* Drug: Shenbai Granules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: meet the colorectal adenomatous polyp diagnosis. polypectomy under colonoscopy;Including snare polypectomy,endoscopic mucosal resection,endoscopic submucosal dissection. aged 18-70. sign informed consent. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: colorectal adenomatous polyp patients after colonoscopy under colonoscopy
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TCM-Shenbai Granules<br>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. | Drug: Shenbai Granules<br>* In the first year, the trial granules will be started after enrollment for 3 months; In the second year, the trial granules will be started in the first 3 months; Each participant should have completed 6 months of trial granules.<br>* Other names: placebo;|
| Placebo Comparator: TCM-Placebo<br>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. | Drug: Shenbai Granules<br>* In the first year, the trial granules will be started after enrollment for 3 months; In the second year, the trial granules will be started in the first 3 months; Each participant should have completed 6 months of trial granules.<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma detection rate | 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. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The detection rate of any polypoid lesions | The ratio of the number of patients with any polypoid lesions detected by colonoscopy to the total number of cases in this group during follow-up. | 2 years | 
| The detection rate of high-risk adenomas | The ratio of the number of patients with high-risk adenomas detected by colonoscopy to the total number of cases in this group during follow-up. | 2 years | 
| The detection rate of sessile serrated lesions | The ratio of the number of patients with sessile serrated lesions detected by colonoscopy to the total number of cases in this group during follow-up. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal adenoma, Clinical curative effect, Complementary and alternative medicine