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

Gastroenterology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03616444
• Other study ID #: 2017YFC1700602
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: December 3, 2018
• Est. completion date: June 28, 2023

Study information

• Verified date: November 2023
• Source: Jiangsu Famous Medical Technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: June 28, 2023
• Est. primary completion date: June 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenoma
• Gastroenterology

Intervention

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.

Locations

Country	Name	City	State
China	Affiliated Hospital of Nanjing University of TCM	Nanjing	Jiangsu

Sponsors (10)

Lead Sponsor	Collaborator
Jiangsu Famous Medical Technology Co., Ltd.	Beijing Friendship Hospital, Changhai Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, Nanjing University of 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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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