Shenbai Granules for Preventing Malignant Transformation of High-risk Colorectal Adenomas

Launched by JIANGSU FAMOUS MEDICAL TECHNOLOGY CO., LTD. · Aug 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether Shenbai Granules, a traditional Chinese medicine, can help prevent high-risk colorectal adenomas—these are certain types of growths in the colon that could turn into cancer if not treated. The study will include 450 adults aged 40 to 75 who have recently had these high-risk growths completely removed through a colonoscopy. Participants will be randomly assigned to take either Shenbai Granules or a placebo (a harmless, inactive treatment) for six months, and then they will be followed for three years to see if new high-risk growths develop or if colorectal cancer occurs.

To join the trial, people must have had a recent high-quality colonoscopy with all polyps removed, meet specific traditional Chinese medicine criteria related to their body’s condition (called “spleen deficiency with dampness-heat”), and agree to regular follow-up visits. People with other serious health issues, certain family cancer histories, or who are pregnant won’t be eligible. Participants can expect to take the study medication for six months and have regular check-ups over the next three years to monitor their colon health. This research aims to find a safe way to reduce the chance that these high-risk growths come back or develop into cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• All of the following criteria must be met for enrolment:
• • 1. Aged 40-75 years, regardless of gender;
• • 2. 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;
• • 3. Complete endoscopic resection of every detected lesion;
• • 4. TCM syndrome differentiation of "spleen deficiency with dampness-heat";
• • 5. Signed informed consent and willingness to comply with long-term follow-up. a: High-quality colonoscopy criteria: Boston Bowel Preparation Scale score ≥ 6, cecal intubation confirmed by visualization of the ileocecal valve, and withdrawal time (excluding biopsy and polypectomy) ≥ 6 minutes.
• Exclusion Criteria:
• Participants who meet any of the following criteria will be excluded from the trial:
• • 1. Concomitant malignancy or history of malignancy in the digestive system;
• • 2. Personal or family history of familial adenomatous polyposis or hereditary non-polyposis colorectal cancer (Lynch syndrome);
• • 3. History of inflammatory bowel disease;
• • 4. 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;
• • 5. Clinically significant organic disorders or neuro-psychiatric conditions that may affect treatment or prognosis, including but not limited to severe cardiovascular or cerebrovascular disease, autoimmune disease, motor, haematological, gastrointestinal, respiratory, immune, circulatory, reproductive, genitourinary, or endocrine disorders; coagulation abnormalities; or serious post-procedural complications (e.g., gastrointestinal bleeding, perforation, cholangitis, intra-abdominal infection, cardiorespiratory depression, mesenteric tear, or pneumoperitoneum), serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2.5 × the upper limit of normal (ULN), or alkaline phosphatase (ALP) \>2 × ULN;
• • 6. Active gastrointestinal disease, conditions predisposing to perforation, or disorders that could substantially interfere with the absorption, distribution, metabolism, or excretion of the investigational drug, such as inability to take oral medication, uncontrolled nausea or vomiting, intestinal obstruction, or chronic diarrhoea;
• • 7. Within 3 months before screening, continuous use for ≥3 months of ≥2 doses per week (with \<2-week interruption) of agents potentially protective against colorectal adenoma: NSAIDs (e.g., aspirin, ibuprofen, celecoxib), metformin, berberine hydrochloride, folic acid, vitamin D, selenium, calcium, systemic immunotherapy, or Chinese patent medicines or decoctions labelled for "tonifying spleen and augmenting qi, clearing heat and eliminating dampness". Subjects may be enrolled after a washout of 1 month or ≥5 drug half-lives, whichever is longer;
• • 8. Cold-pattern manifestations such as aversion to cold, cold pain in the waist/abdomen, cold extremities, or preference for hot drinks;
• • 9. Pregnant or lactating women, or men and women of child-bearing potential with plans to conceive during the trial or within 7 months after trial completion;
• • 10. Participation in another drug or device trial within 1 month or \< 5 half-lives of the investigational agent (whichever is longer) before screening, concurrent participation in another trial, or intention to participate in any other clinical trial during this trial;
• • 11. Known allergy or hypersensitivity to ≥ 2 drugs or foods, or hypersensitivity to any component of the trial medication;
• • 12. Any other condition that, in the opinion of the investigator, makes the subject unsuitable for enrolment (e.g., poor expected compliance, cognitive impairment).