Skip to main content
OpenTrials
Completed

NCT Number: NCT03616444

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Affiliated Hospital of Nanjing University of TCM

Nanjing, Jiangsu, 210029, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Shenbai Granules

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.

Other names: placebo

Primary outcomes

  1. Adenoma detection rate

    Time frame: 2 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 outcomes

  1. The detection rate of any polypoid lesions

    Time frame: 2 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.

  2. The detection rate of high-risk adenomas

    Time frame: 2 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.

  3. The detection rate of sessile serrated lesions

    Time frame: 2 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.

Sponsors and collaborators

Lead sponsor

Jiangsu Famous Medical Technology Co., Ltd.

Industry

Collaborators

  • Affiliated Hospital of Nanjing University of Chinese Medicine
  • Beijing Friendship Hospital
  • Changhai Hospital
  • Guangdong Provincial Hospital of Traditional Chinese Medicine
  • Shanghai University of Traditional Chinese Medicine
  • ShuGuang Hospital
  • The First Affiliated Hospital with Nanjing Medical University
  • The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine
  • West China Hospital

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Aug 6, 2018
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.