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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-03

Study Completion Date

2023-06-28

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.

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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.

Conditions

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Gastroenterology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

colorectal adenomatous polyp patients after colonoscopy under colonoscopy

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

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.

Study Groups

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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.

Group Type EXPERIMENTAL

Shenbai Granules

Intervention Type DRUG

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.

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.

Group Type PLACEBO_COMPARATOR

Shenbai Granules

Intervention Type DRUG

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.

Interventions

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Shenbai Granules

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.

Intervention Type DRUG

Other Intervention Names

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placebo

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No