Colorectal AdenomaNCT07129499
Shenbai Granules for Preventing Malignant Transformation of High-risk Colorectal Adenomas
A study testing Shenbai Granules in people with Colorectal Adenoma and High Risk, run by Jiangsu Famous Medical Technology Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Colorectal Adenoma, High Risk, TCM
- What is being tested?
- Shenbai Granules
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2025to 30 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Affiliated Hospital of Nanjing University of Chinese Medicine
Nanjing, Jiangsu
Haibo Cheng, Professor, 025-85811001, hbcheng@njucm.edu.cn
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-Controlled Clinical Trial of Shenbai Granules for Preventing Malignant Transformation of High-Risk Colorectal Adenomas
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.
Read the detailed description
High-risk colorectal adenomas (HR-CRAs) are a recognized precursor lesion for colorectal cancer, with 25-40% of patients developing metachronous adenomas within 3 years after endoscopic resection. Low-dose aspirin is the only agent supported by high-level evidence for reducing the incidence of metachronous HR-CRAs, but its use is limited by bleeding risks. Although previous studies on the traditional Chinese medicine compound Shenbai Granules (SBG) have suggested its potential in preventing metachronous HR-CRAs, sufficient evidence from randomised controlled trials (RCTs) is still lacking. This trial aims to confirm the efficacy and safety of SBG in preventing the development of metachronous adenomas and subsequent carcinogenesis, and to identify clinical predictors of treatment response to define the optimal target population. This multicentre, randomised, double-blind, placebo-controlled trial will enroll 450 patients with endoscopically resected HR-CRAs. Participants will be randomly allocated 1:1 to receive either SBG (n=225) or a matching placebo (n=225). The trial comprises a 14-day screening period, a 6-month treatment phase, and a 30-month surveillance phase, including four on-site visits and one telephone follow-up. The primary endpoint is the three-year cumulative incidence of metachronous HR-CRA. Secondary endpoints include the incidence of metachronous low-risk adenomas and serrated lesions within the same 3-year window, cumulative number and size of lesions, anatomic distribution, histopathology, and the incidence of colorectal cancer.
- Conditions
- Colorectal Adenoma, High Risk, TCM
- Being tested
- Shenbai Granules, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shenbai GranulesDrug
Also called Treatment group
10 g/bag, two bags each time, twice a day, monthly for 30 days for 6 months.
PlaceboDrug
Also called Control group
10 g/bag, two bags each time, twice a day, monthly for 30 days for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1, 3 years
Secondary outcomes (13)
Cumulative detection rate of metachronous low-risk colorectal adenomas within 3 years after the first dose.
The proportion of patients found to have metachronous low-risk colorectal adenomas during surveillance colonoscopy within 3 years after baseline adenoma resection. Colonoscopy will be performed in the first and third years.
Measured: 1, 3 years
Cumulative counts of metachronous colorectal adenomas detected within 3 years after the first dose.
The cumulative counts of metachronous colorectal adenomas detected during colonoscopic surveillance within 3 years after baseline adenoma resection. Colonoscopy will be performed in the first and third years.
Measured: 1, 3 years
The average number of metachronous colorectal adenomas detected within 3 years after the first dose.
The average number of metachronous colorectal adenomas detected during colonoscopic surveillance within 3 years after baseline adenoma resection. Colonoscopy will be performed in the first and third years.
Measured: 1, 3 years
Size of metachronous colorectal adenomas detected within 3 years after the first dose.
The average size of metachronous colorectal adenomas detected during colonoscopic surveillance within 3 years after baseline adenoma resection. Colonoscopy will be performed in the first and third years.
Measured: 1, 3 years
Location of metachronous colorectal adenomas detected within 3 years after the first dose.
The location (left colon, right colon, rectum) of metachronous colorectal adenomas detected during colonoscopic surveillance within 3 years after baseline adenoma resection. Colonoscopy will be performed in the first and third years.
Measured: 1, 3 years
Pathology of metachronous colorectal adenomas detected within 3 years after the first dose.
The pathological types (histological architecture: tubular adenoma, villous adenoma, tubulovillous adenoma; and degree of dysplasia: high-grade intraepithelial neoplasia, low-grade intraepithelial neoplasia) of metachronous colorectal adenomas detected during colonoscopic surveillance within 3 years after baseline adenoma resection. Colonoscopy will be performed in the first and third years.
Measured: 1, 3 years
Cumulative detection rate of serrated lesions within 3 years after the first dose.
The proportion of cases with serrated lesions identified during colonoscopy surveillance within 3 years after baseline adenoma resection, relative to the total number of cases in the cohort. Colonoscopy will be performed in the first and third years.
Measured: 1, 3 years
Cumulative incidence of serrated lesions detected within 3 years after the first dose.
The cumulative incidence of serrated lesions detected during colonoscopic surveillance within 3 years after baseline adenoma resection. Colonoscopy will be performed in the first and third years.
Measured: 1, 3 years
The average number of serrated lesions detected within 3 years after the first dose.
The average number of serrated lesions detected during colonoscopic surveillance within 3 years after baseline adenoma resection. Colonoscopy will be performed in the first and third years.
Measured: 1, 3 years
Size of serrated lesions detected within 3 years after the first dose.
The average size of serrated lesions detected during colonoscopic surveillance within 3 years after baseline adenoma resection. Colonoscopy will be performed in the first and third years.
Measured: 1, 3 years
Location of serrated lesions detected within 3 years after the first dose.
The location distribution (left colon, right colon, rectum) of serrated lesions detected during colonoscopic surveillance within 3 years after baseline adenoma resection. Colonoscopy will be performed in the first and third years.
Measured: 1, 3 years
Pathological types of all serrated lesions detected within 3 years after the first dose.
The pathological types (colorectal serrated lesion, sessile serrated lesion, hyperplastic polyp) of serrated lesions will be detected during colonoscopic surveillance within 3 years after baseline adenoma resection. Colonoscopy will be performed in the first and third years.
Measured: 1, 3 years
Incidence of colorectal cancer within 3 years after the first dose.
The proportion of cases with interval colorectal cancer detected during surveillance colonoscopy within 3 years after baseline adenoma resection, relative to the total number of cases in the cohort. Colonoscopy will be performed in the first and third years.
Measured: 1, 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start15 Aug 2025 (estimated)
- Primary completion30 Nov 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal AdenomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Famous Medical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital with Nanjing Medical University, First Affiliated Hospital of Harbin Medical University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing Traditional Chinese Medicine Hospital, 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, RenJi Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07129499
- Sponsor's protocol ID
- 2024ZD0520804
- Status last verified
- Aug 2025
- First submitted
- 7 Aug 2025
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-Controlled Clinical Trial of Shenbai Granules for Preventing Malignant Transformation of High-Risk Colorectal Adenomas
- ClinicalTrials.gov ID
- NCT07129499
- Acronym / sponsor ID
- 2024ZD0520804
- Conditions
- Colorectal Adenoma, High Risk, TCM
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Jiangsu Famous Medical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital with Nanjing Medical University, First Affiliated Hospital of Harbin Medical University, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing Traditional Chinese Medicine Hospital, 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, RenJi Hospital
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
High-risk colorectal adenomas (HR-CRAs) are a recognized precursor lesion for colorectal cancer, with 25-40% of patients developing metachronous adenomas within 3 years after endoscopic resection. Low-dose aspirin is the only agent supported by high-level evidence for reducing the incidence of metachronous HR-CRAs, but its use is limited by bleeding risks. Although previous studies on the traditional Chinese medicine compound Shenbai Granules (SBG) have suggested its potential in preventing metachronous HR-CRAs, sufficient evidence from randomised controlled trials (RCTs) is still lacking. This trial aims to confirm the efficacy and safety of SBG in preventing the development of metachronous adenomas and subsequent carcinogenesis, and to identify clinical predictors of treatment response to define the optimal target population. This multicentre, randomised, double-blind, placebo-controlled trial will enroll 450 patients with endoscopically resected HR-CRAs. Participants will be randomly allocated 1:1 to receive either SBG (n=225) or a matching placebo (n=225). The trial comprises a 14-day screening period, a 6-month treatment phase, and a 30-month surveillance phase, including four on-site visits and one telephone follow-up. The primary endpoint is the three-year cumulative incidence of metachronous HR-CRA. Secondary endpoints include the incidence of metachronous low-risk adenomas and serrated lesions within the same 3-year window, cumulative number and size of lesions, anatomic distribution, histopathology, and the incidence of colorectal cancer.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shenbai Granules | Experimental | Drug: Shenbai GranulesShenbai 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. |
| Placebo | Placebo comparator | Drug: PlaceboThe 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shenbai GranulesAlso: Treatment group10 g/bag, two bags each time, twice a day, monthly for 30 days for 6 months. | Drug | Shenbai Granules |
| PlaceboAlso: Control group10 g/bag, two bags each time, twice a day, monthly for 30 days for 6 months. | Drug | Placebo |
Primary outcome
Cumulative detection rate of metachronous high-risk colorectal adenomas within 3 years after the first dose.
Time frame: 1, 3 years
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.
13 secondary outcomes
Cumulative detection rate of metachronous low-risk colorectal adenomas within 3 years after the first dose.
Time frame: 1, 3 years
Cumulative counts of metachronous colorectal adenomas detected within 3 years after the first dose.
Time frame: 1, 3 years
The average number of metachronous colorectal adenomas detected within 3 years after the first dose.
Time frame: 1, 3 years
Size of metachronous colorectal adenomas detected within 3 years after the first dose.
Time frame: 1, 3 years
Location of metachronous colorectal adenomas detected within 3 years after the first dose.
Time frame: 1, 3 years
Pathology of metachronous colorectal adenomas detected within 3 years after the first dose.
Time frame: 1, 3 years
Cumulative detection rate of serrated lesions within 3 years after the first dose.
Time frame: 1, 3 years
Cumulative incidence of serrated lesions detected within 3 years after the first dose.
Time frame: 1, 3 years
The average number of serrated lesions detected within 3 years after the first dose.
Time frame: 1, 3 years
Size of serrated lesions detected within 3 years after the first dose.
Time frame: 1, 3 years
Location of serrated lesions detected within 3 years after the first dose.
Time frame: 1, 3 years
Pathological types of all serrated lesions detected within 3 years after the first dose.
Time frame: 1, 3 years
Incidence of colorectal cancer within 3 years after the first dose.
Time frame: 1, 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shenbai Granules in people with Colorectal Adenoma and High Risk, run by Jiangsu Famous Medical Technology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haibo Cheng, Professor (025-85811001, hbcheng@njucm.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative detection rate of metachronous high-risk colorectal adenomas within 3 years after the first dose. (time frame: 1, 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.