NCT03616444

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: Jiangsu Famous Medical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Gastroenterology

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-12-03
• Primary completion: 2023-06-28
• Completion: 2023-06-28
• First posted: 2018-08-06
• Last updated: 2023-11-13

Locations

1 site across 1 country: China