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

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

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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