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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
450
Dosage: bag 10g per , administered twice daily continuously for 180 days.
Dosage: 10g per bag, administered twice daily continuously for 180 days.
Affiliated Hospital of Nanjing University of Chinese Medicine
Nanjing, Jiangsu, China
Detection rate of metachronous colorectal adenoma within 3 years after initial administration.
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.
Time frame: 3 years
Cumulative number, quantity, size, location, and pathology of detected metachronous colorectal adenomas within 3 years after initial administration.
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.
Time frame: 3 years
Detection rate of serrated lesions within 3 years after initial administration.
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.
Time frame: 3 years
Cumulative number, quantity, size, location, and pathology of detected serrated lesions within 3 years after initial administration.
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.
Time frame: 3 years
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