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

Phase 2
Completed
Conditions
Gastroenterology
Interventions
Drug: Shenbai Granules
Registration Number
NCT03616444
Lead Sponsor
Jiangsu Famous Medical Technology Co., Ltd.
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
400
Inclusion Criteria
  1. meet the colorectal adenomatous polyp diagnosis.
  2. polypectomy under colonoscopy;Including snare polypectomy,endoscopic mucosal resection,endoscopic submucosal dissection.
  3. aged 18-70.
  4. sign informed consent.
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Exclusion Criteria
  1. colonoscopy was reported, but no pathological findings were found.
  2. patients with hereditary polyposis.
  3. there is reliable evidence that the tumor has infiltrated into the intrinsic mucosal layer,or deep infiltration under the mucosa is suspected.
  4. combined with colorectal malignancy or previous history of colorectal malignancy.
  5. colonoscopy highly suggests inflammatory bowel disease.
  6. pregnant and lactating women.
  7. women who recently have a planning pregnant programme.
  8. prone to bleeding and using anticoagulants.
  9. 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.
  10. unstable vital signs.
  11. suspect or have a history of alcohol or drug abuse.
  12. frequent changes in the working environment or other circumstances are likely to cause loss of interview.
  13. drugs (aspirin, folic acid, vitamin D, calcium) with potential to treat colorectal adenomas have been used.
  14. those who are participating in other clinical trials.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
TCM-Shenbai GranulesShenbai GranulesShenbai 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.
TCM-PlaceboShenbai GranulesIt 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.
Primary Outcome Measures
NameTimeMethod
Adenoma detection rate2 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.

Secondary Outcome Measures
NameTimeMethod
The detection rate of sessile serrated lesions2 years

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.

The detection rate of any polypoid lesions2 years

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.

The detection rate of high-risk adenomas2 years

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.

Trial Locations

Locations (1)

Affiliated Hospital of Nanjing University of TCM

🇨🇳

Nanjing, Jiangsu, China

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