Shenbai Granules for Preventing Malignant Transformation of High-risk Colorectal Adenomas
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-75
SponsorJiangsu Famous Medical Technology Co., Ltd.
About this trial
This multicenter, randomized, double-blind, placebo-controlled trial will enroll 450 patients with completely resected high-risk colorectal adenoma (HR-CRA), randomly assigned (1:1) to 6 months of Shenbai Granules (SBG) or placebo, followed for 3 years post-polypectomy. Primary endpoint: 3-year cumulative incidence of metachronous HR-CRA. Secondary endpoints: incidence, number, size, distribution, histology of low-risk adenomas and serrated lesions, and colorectal cancer occurrence.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 40-75 years, regardless of gender;
High-quality colonoscopy performed within 14 days before randomisation, with initial endoscopic resection of all polyps and histological confirmation of at least one HR-CRA criteria;
Complete endoscopic resection of every detected lesion;
TCM syndrome differentiation of "spleen deficiency with dampness-heat";
Disqualifiers
Concomitant malignancy or history of malignancy in the digestive system;
Personal or family history of familial adenomatous polyposis or hereditary non-polyposis colorectal cancer (Lynch syndrome);
History of inflammatory bowel disease;
Malignancy in any other organ system within 5 years before screening, except for adequately treated thyroid carcinoma, cervical carcinoma in situ, basal or squamous cell skin carcinoma, or ductal carcinoma in situ of the breast cured by radical surgery;
Trial design
Design model
Parallel
Treatments tested in this trial
Shenbai Granules
Drug10 g/bag, two bags each time, twice a day, monthly for 30 days for 6 months.
Placebo
Drug10 g/bag, two bags each time, twice a day, monthly for 30 days for 6 months.
Treatment groups
450 Participants
are divided into 2 treatment groupsGroup A: Shenbai GranulesExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Cumulative detection rate of metachronous high-risk colorectal adenomas within 3 years after the first dose.
The proportion of patients found to have metachronous high-risk colorectal adenomas during surveillance colonoscopy within 3 years after baseline adenoma resection. Colonoscopy will be performed in the first and third years.
Time frame
1, 3 yearsSecondary outcomes
1
Cumulative detection rate of metachronous low-risk colorectal adenomas within 3 years after the first dose.
The proportion of patients found to have metachronous low-risk colorectal adenomas during surveillance colonoscopy within 3 years after baseline adenoma resection. Colonoscopy will be performed in the first and third years.
Time frame
1, 3 years2
Cumulative counts of metachronous colorectal adenomas detected within 3 years after the first dose.
The cumulative counts of metachronous colorectal adenomas detected during colonoscopic surveillance within 3 years after baseline adenoma resection. Colonoscopy will be performed in the first and third years.
Time frame
1, 3 years3
The average number of metachronous colorectal adenomas detected within 3 years after the first dose.
The average number of metachronous colorectal adenomas detected during colonoscopic surveillance within 3 years after baseline adenoma resection. Colonoscopy will be performed in the first and third years.
Time frame
1, 3 years4
Size of metachronous colorectal adenomas detected within 3 years after the first dose.
The average size of metachronous colorectal adenomas detected during colonoscopic surveillance within 3 years after baseline adenoma resection. Colonoscopy will be performed in the first and third years.
Time frame
1, 3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Jiangsu Famous Medical Technology Co., Ltd.
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
Collaborator
First Affiliated Hospital of Harbin Medical University
Collaborator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborator
The Second Affiliated Hospital of Chongqing Medical University
Collaborator
Chongqing Traditional Chinese Medicine Hospital
Collaborator
The Second Hospital of Shandong University
Collaborator
Shengjing Hospital
Collaborator
Shenzhen Hospital of Southern Medical University
Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University
Collaborator
Sichuan Provincial People's Hospital
Collaborator
Shanxi Provincial People's Hospital
Collaborator
Affiliated Hospital of Nanjing University of Chinese Medicine
Collaborator
RenJi Hospital
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: