Shenbai Granules for Preventing Recurrence of Low-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
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 40-75 years, regardless of sex;
Patients with histologically confirmed high-risk adenomas undergoing initial polypectomy, with high-quality colonoscopy performed within 14 days before randomization;
Complete resection of all detected lesions during colonoscopy;
Meeting TCM diagnostic criteria for spleen deficiency with dampness-heat syndrome;
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Shenbai Granules
DrugDosage: bag 10g per , administered twice daily continuously for 180 days.
Placebo
DrugDosage: 10g per bag, administered twice daily continuously for 180 days.
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
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 yearsSecondary outcomes
1
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 years2
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 years3
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 yearsSponsors and contacts
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Jiangsu Famous Medical Technology Co., Ltd.
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
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
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborator
Source ClinicalTrials.gov
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