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

J

Jiangsu Famous Medical Technology

Status and phase

Completed
Phase 3
Phase 2

Conditions

Gastroenterology

Treatments

Drug: Shenbai Granules

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03616444
2017YFC1700602

Details and patient eligibility

About

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.

Full 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.

Enrollment

400 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

400 participants in 2 patient groups, including a placebo group

TCM-Shenbai Granules
Experimental group
Description:
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.
Treatment:
Drug: Shenbai Granules
TCM-Placebo
Placebo Comparator group
Description:
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.
Treatment:
Drug: Shenbai Granules

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Zhou Qing, PhD; Chen Haibo, PhD

Data sourced from clinicaltrials.gov

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