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

NCT07129499 | Not Yet Recruiting DMC

• 1 other identifier: 2024ZD0520804
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Adenoma; High Risk; TCM

Outcome Measures

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.

  1, 3 years

Secondary Outcomes (13)

• Cumulative detection rate of metachronous low-risk colorectal adenomas within 3 years after the first dose.

  1, 3 years

• Cumulative counts of metachronous colorectal adenomas detected within 3 years after the first dose.

  1, 3 years

• The average number of metachronous colorectal adenomas detected within 3 years after the first dose.

  1, 3 years

• Size of metachronous colorectal adenomas detected within 3 years after the first dose.

  1, 3 years

• Location of metachronous colorectal adenomas detected within 3 years after the first dose.

  1, 3 years

Study Arms (2)

Shenbai Granules

EXPERIMENTAL

Shenbai Granules is a traditional Chinese medicine preparation formulated from eight herbal ingredients, including Sophorae Flavescentis Radix (Kushen), Coptidis Rhizoma (Huanglian), and other herbs. It exerts therapeutic effects by clearing heat and drying dampness, while simultaneously invigorating the spleen and replenishing qi.

Drug: Shenbai Granules

Placebo

PLACEBO COMPARATOR

The placebo was formulated using Shenbai Granules dry extract powder at 2% (w/w) of the equivalent dose found in the compound herbal granules, supplemented with colorants and flavoring agents to ensure visual and gustatory consistency with the Shenbai Granules.

Drug: Placebo

Interventions

Shenbai Granules DRUG

10 g/bag, two bags each time, twice a day, monthly for 30 days for 6 months.

Also known as: Treatment group

Shenbai Granules

Placebo DRUG

10 g/bag, two bags each time, twice a day, monthly for 30 days for 6 months.

Also known as: Control group

Placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All of the following criteria must be met for enrolment:
• 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";
• 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.

You may not qualify if:

• Participants who meet any of the following criteria will be excluded from the trial:
• 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;
• 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;
• 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;
• 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;
• Cold-pattern manifestations such as aversion to cold, cold pain in the waist/abdomen, cold extremities, or preference for hot drinks;
• 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;
• 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;
• Known allergy or hypersensitivity to ≥ 2 drugs or foods, or hypersensitivity to any component of the trial medication;
• Any other condition that, in the opinion of the investigator, makes the subject unsuitable for enrolment (e.g., poor expected compliance, cognitive impairment).

Sponsors & Collaborators

• Jiangsu Famous Medical Technology Co., Ltd.: lead
• 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

Study Sites (1)

Affiliated Hospital of Nanjing University of Chinese Medicine

Nanjing, Jiangsu, China

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Haibo Cheng, Professor

CONTACT

025-85811001; hbcheng@njucm.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 19, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: August 19, 2025

Record last verified: 2025-08

Locations

CN (1)