Multi-center Randomized Controlled Clinical Study of Shenling Baishu Granule to Prevent the Recurrence of Low-risk Colorectal Adenoma
NCT ID: NCT06930157
Last Updated: 2026-01-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
624 participants
INTERVENTIONAL
2025-11-24
2028-12-31
Brief Summary
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2. Generate high-level, internationally recognized clinical evidence to support the development of clinical practice guidelines for the prevention and treatment of colorectal adenoma using traditional Chinese medicine, and to strengthen the recommendation level of Shenling Baizhu Granules in clinical guidelines.
3. Define the clinical characteristics of patient subgroups most likely to benefit from Shenling Baizhu Granules for preventing colorectal adenoma recurrence.
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Detailed Description
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At baseline, demographic characteristics, adenoma-related information, and TCM syndrome assessment scores will be collected. Follow-up will be conducted every 6 months during the first 2 years, and once in the third year. Biospecimens and TCM assessments will be collected at three time points: (i) baseline, (ii) 6 months after initiation of medication in Year 1, and (iii) after colonoscopic reassessment in Year 3. At each time point, plasma, stool, tongue coating, saliva, and tissue samples, as well as the TCM syndrome assessment questionnaire, will be obtained.
To characterize the subpopulation most likely to benefit from Shenling Baizhu Granules in preventing colorectal adenoma recurrence, we will integrate and analyze: baseline clinical factors (e.g., age, sex, family history of cancer, smoking and alcohol use); conventional medical features (e.g., adenoma location, number, size, histopathological type, and concomitant medications); TCM-related features (e.g., evolution of TCM syndrome patterns and objective tongue/pulse parameters); and biological profiles (e.g., cytokines, proteins, metabolites, and gut microbiota). Common characteristics of the beneficial population will then be summarized based on these multidimensional data.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Experimental Group (Shenling Baizhu Granules)
Participants will take Shenling Baizhu granules (6 g, three times daily) for 6 months, started within 3 months after standard endoscopic treatment, in addition to basic health education.
Shenling Baizhu granules (TCM patent medicine)
Shenling Baizhu granules is a traditional Chinese medicine preparation in granular form. Participants in the experimental group will take 6 g orally three times daily for 6 months, initiated within 3 months after baseline endoscopic resection and health education. The granules should be taken before meals or at the same time as eating. The granules contain multiple Chinese herbs including Ginseng, Poria, Atractylodes macrocephala, and other traditional ingredients. This formulation is standardized according to Chinese pharmacopoeia standards and is manufactured under GMP conditions. This intervention is being tested for its ability to prevent the recurrence of low-risk colorectal adenomas after endoscopic resection.
Control Group (No intervention)
Participants will receive only basic health education without taking Shenling Baizhu granules.
No interventions assigned to this group
Interventions
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Shenling Baizhu granules (TCM patent medicine)
Shenling Baizhu granules is a traditional Chinese medicine preparation in granular form. Participants in the experimental group will take 6 g orally three times daily for 6 months, initiated within 3 months after baseline endoscopic resection and health education. The granules should be taken before meals or at the same time as eating. The granules contain multiple Chinese herbs including Ginseng, Poria, Atractylodes macrocephala, and other traditional ingredients. This formulation is standardized according to Chinese pharmacopoeia standards and is manufactured under GMP conditions. This intervention is being tested for its ability to prevent the recurrence of low-risk colorectal adenomas after endoscopic resection.
Eligibility Criteria
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Inclusion Criteria
* Has undergone a colonoscopy of adequate quality (adequate bowel preparation, cecal intubation achieved, and withdrawal time ≥6 minutes) and received endoscopic minimally invasive polypectomy.
* Within 3 months after adenoma resection.
* 18-70 years of age; any sex.
* Willing to participate and has voluntarily provided written informed consent.
Exclusion Criteria
* Long-term use of aspirin, folic acid, calcium supplements, vitamin D, or similar agents.
* Known hereditary polyposis syndromes (e.g., familial adenomatous polyposis) or hereditary colorectal cancer syndromes (e.g., Lynch syndrome/hereditary nonpolyposis colorectal cancer).
* Colonoscopy findings strongly suggestive of inflammatory bowel disease.
* History of malignancy within the past 5 years.
* Pregnant or breastfeeding women, or participants with pregnancy potential who are planning pregnancy.
* Severe cardiovascular or cerebrovascular disease, hepatic or renal insufficiency, or diabetes mellitus.
* Severe psychiatric disorders that would preclude cooperation with colonoscopy procedures.
* Current condition preventing oral administration of the study drug (e.g., dysphagia, chronic diarrhea, intestinal obstruction).
* Participation in another clinical study within the past 3 months or current participation in another clinical study.
* Any other condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.
18 Years
70 Years
ALL
No
Sponsors
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Affiliated Hospital of Nanjing University of Chinese Medicine
OTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Sixth Affiliated Hospital, Sun Yat-sen University
OTHER
Shuguang Hospital of Shanghai University of Traditional Chinese Medicine
UNKNOWN
Beijing Friendship Hospital
OTHER
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine
UNKNOWN
Institute of Science, Beijing Tongrentang Co., Ltd.
UNKNOWN
Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Xiaobo Li
Principal Investigator
Locations
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Renji Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Other Identifiers
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KY2024-191-C
Identifier Type: -
Identifier Source: org_study_id
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