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| Name | Class |
|---|---|
| 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 |
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This study is designed within the traditional Chinese medicine (TCM) framework for colorectal adenoma and will be conducted as a prospective, multicenter, open-label, randomized, blank-controlled clinical trial. All participants will undergo standard endoscopic minimally invasive treatment and receive health education. In addition to these measures, participants in the intervention group will receive Shenling Baizhu Granules (6 g per dose, three times daily). The intervention will be initiated within 3 months after the baseline treatment/health education and continued for 6 consecutive months. Participants in the control group will not receive Shenling Baizhu Granules.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group (Shenling Baizhu Granules) | Experimental | 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. |
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| Control Group (No intervention) | No Intervention | Participants will receive only basic health education without taking Shenling Baizhu granules. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shenling Baizhu granules (TCM patent medicine) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of metachronous low-risk adenomas within 3 years after first dose | The incidence of metachronous low-risk adenomas will be calculated for each group as the number of participants with metachronous low-risk adenomas detected on surveillance colonoscopy within 3 years of enrollment divided by the total number of participants in that group. | At 3 years after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Colorectal adenoma progression rate | The progression rate will be calculated for each group as the number of participants in whom colorectal adenoma progression (defined as high-risk adenoma and/or malignant transformation) is detected on surveillance colonoscopy within 3 years after enrollment divided by the total number of participants in that group. | At 3 years after enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaobo Li | Contact | +86021-58752345 | lxb_1969@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
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| Shuguang Hospital of Shanghai University of Traditional Chinese Medicine | UNKNOWN |
| Beijing Friendship Hospital | OTHER |
| Yueyang Hospital of Integrated Traditional Chinese and Western Medicine | OTHER |
| Institute of Science, Beijing Tongrentang Co., Ltd. | UNKNOWN |
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| TCM syndrome score | The Traditional Chinese Medicine Syndrome Survey assesses bowel habits, abdominal symptoms, and secondary symptoms like oral discomfort and appetite, with scores ranging from 0 (no symptoms) to higher values indicating increasing severity, alongside tongue and pulse observations. | At baseline, 6 months, and 36 months |