Colorectal Adenoma, Low Risk, TCM
Conditions
Brief summary
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Shenbai Granules for Preventing Recurrence of Low-Risk Colorectal Adenomas（LRCRA）. Study Population: Post-resection patients with low-risk colorectal adenomas and Spleen Deficiency with Dampness-Heat Syndrome per TCM criteria. Sample Size: 450 subjects (1:1 randomization; 225 per arm) accounting for ≤20% dropout. Study Hypothesis (Exploratory) ： This exploratory trial aims to evaluate the potential efficacy and safety of Shenbai Granules, a TCM formula, in reducing LRCRA recurrence. Based on preliminary data suggesting a 32.64% relative risk reduction in LRCRA recurrence at 2 years, we hypothesize that Shenbai Granules may demonstrate clinically meaningful prevention of adenoma recurrence and offer a favorable safety profile in the target TCM syndrome population. No formal statistical hypothesis is tested. Statistical Analysis Analysis Sets: mITT (primary efficacy), PPS, SS (safety). Primary Analysis: Proportion difference (Newcombe method) and χ²/Fisher's exact test (stratified CMH if applicable). Sensitivity analyses: PPS, tipping-point imputation for missing data. Safety: Descriptive summaries of AEs/SAEs (MedDRA-coded), lab abnormalities.
Interventions
DRUGShenbai Granules
Dosage: bag 10g per , administered twice daily continuously for 180 days.
DRUGPlacebo
Dosage: 10g per bag, administered twice daily continuously for 180 days.
Sponsors
The First Affiliated Hospital with Nanjing Medical University
The Second Hospital of Shandong University
Shengjing Hospital
Shenzhen Hospital of Southern Medical University
Sixth Affiliated Hospital, Sun Yat-sen University
Sichuan Provincial People's Hospital
Shanxi Provincial People's Hospital
Affiliated Hospital of Nanjing University of Chinese Medicine
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Jiangsu Famous Medical Technology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
To be eligible for this study, all of the following inclusion criteria must be met: 1. Aged 40-75 years, regardless of sex; 2. Patients with histologically confirmed high-risk adenomas undergoing initial polypectomy, with high-quality colonoscopy performed within 14 days before randomization; 3. Complete resection of all detected lesions during colonoscopy; 4. Meeting TCM diagnostic criteria for spleen deficiency with dampness-heat syndrome; 5. Provision of signed informed consent and ability to comply with long-term follow-up. 1. High-quality colonoscopy is defined as: Boston Bowel Preparation Scale (BBPS) score ≥6, cecal intubation with photo-documentation and withdrawal time ≥6 minutes. If quality standards cannot be confirmed, a repeat colonoscopy is required. \-
Exclusion criteria
Subjects who meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection rate of metachronous colorectal adenoma within 3 years after initial administration. | 3 years | the proportion of patients with detected metachronous colorectal adenomas during surveillance colonoscopy performed within 3 years after baseline polypectomy or adenoma resection to the total number of patients in the group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative number, quantity, size, location, and pathology of detected metachronous colorectal adenomas within 3 years after initial administration. | 3 years | The cumulative number, mean number, mean size, location distribution (left-sided colon, right-sided colon, rectum), and histological classification (histological architecture: tubular adenoma, villous adenoma, tubulovillous adenoma; dysplasia grade: high-grade intraepithelial neoplasia \[HGIN\], low-grade intraepithelial neoplasia \[LGIN\]) of metachronous colorectal adenomas detected during surveillance colonoscopy performed within 3 years after baseline polypectomy. |
| Detection rate of serrated lesions within 3 years after initial administration. | 3 years | The proportion of patients with detected serrated lesions during surveillance colonoscopy performed within 3 years after baseline polypectomy or adenoma resection to the total number of patients in the group. |
| Cumulative number, quantity, size, location, and pathology of detected serrated lesions within 3 years after initial administration. | 3 years | The cumulative number, mean number, mean size, location distribution (left-sided colon, right-sided colon, rectum), and histological classification (Traditional Serrated Adenoma \[TSA\], Sessile Serrated Lesion \[SSL\], Hyperplastic Polyp \[HP\]) of serrated lesions detected during surveillance colonoscopy performed within 3 years after baseline polypectomy. |
Countries
China
Contacts
Primary ContactHaibo Cheng, Professor
Outcome results
None listed