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

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

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.

Study Overview

• Status: Completed
• Conditions: Gastroenterology
• Intervention / Treatment: Drug: Shenbai Granules

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.

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Zhou Qing, PhD; Phone Number: 86-13601401869; Email: 13601401869@163.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Affiliated Hospital of Nanjing University of TCM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.; Other Names: placebo
Placebo Comparator: 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.	Drug: 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.; Other Names: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adenoma detection rate	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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The detection rate of any polypoid lesions	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 years
The detection rate of high-risk adenomas	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.	2 years
The detection rate of sessile serrated lesions	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.	2 years

Collaborators and Investigators

• Sponsor: Jiangsu Famous Medical Technology Co., Ltd.
• Collaborators: The First Affiliated Hospital with Nanjing Medical University; Changhai Hospital; Guangdong Provincial Hospital of Traditional Chinese Medicine; Beijing Friendship Hospital; West China Hospital; Shanghai University of Traditional Chinese Medicine; ShuGuang Hospital; The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine; Nanjing University of Chinese Medicine
• Investigators: Study Chair: Chen Yugen, PhD, Key members of the study

Publications and helpful links

General Publications

• Zhou Q, Chen YG, Xiao J, Chen TT, Liu JR, Zhou W, Li WZ, Wang Y, Zhang BP, Lin J, Meng FD, Gong B, Zheng GY, Han ST, Cheng HB. Traditional Chinese medicine (Xiaoai Jiedu Decoction) as an adjuvant treatment for prevention new colorectal adenomatous polyp occurrence in post-polypectomy: Study protocol for a randomized controlled trial. Medicine (Baltimore). 2019 Aug;98(31):e16680. doi: 10.1097/MD.0000000000016680.

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2018
• Primary Completion (Actual): June 28, 2023
• Study Completion (Actual): June 28, 2023

Study Registration Dates

• First Submitted: July 26, 2018
• First Submitted That Met QC Criteria: July 27, 2018
• First Posted (Actual): August 6, 2018

Study Record Updates

• Last Update Posted (Actual): November 13, 2023
• Last Update Submitted That Met QC Criteria: November 9, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Complementary and alternative medicine; Clinical curative effect; colorectal adenoma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: 2017YFC1700602

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data supporting the findings of this study are restricted in availability due to patient confidentiality reasons.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No