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| Name | Class |
|---|---|
| Affiliated Hospital of Nanjing University of Chinese Medicine | OTHER |
| Guangdong Provincial Hospital of Traditional Chinese Medicine | OTHER |
| Shanghai University of Traditional Chinese Medicine | OTHER |
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This study evaluates Shenbai Granules in Prevention of Colorectal Adenomatous Polyp Recurrence After Colonoscopy.Half of participants will receive Shenbai Granules,while the other half will receive a placebo.
There is no internationally recognized standard treatment for the prevention of recurrence of colorectal adenomatous polyps.
Based on TCM,previous studies have found that Shenbai Granules can significantly reduce the recurrence and deterioration rate of colorectal adenomatous polyps,reduce the proliferation of tumor cells and promote apoptosis of tumor cells.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TCM-Shenbai Granules | Experimental | Shenbai Granules: Hedyotis diffusa 10g, Sophorae flavescentis radix 4.5g, Codonopsis radix 7.5g, Atractylodis macrocephalae rhizoma 6g, Mume fructus 4.5g, Coptidis rhizoma 1.5g, Zingiberis rhizome praeparatum 3g, Coicis semen 10g. Orally, 1 sachet once, diluted in 150-200 ml of boiling water, 2 times a day. |
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| TCM-Placebo | Placebo Comparator | It contains 5% SBG content, and the remaining ingredients are flavoring agents, starch and coloring agents. It is the same with SBG in appearance, smell and dosage form. Orally, 1 sachet once, diluted in 150-200 ml of boiling water, 2 times a day. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shenbai Granules | Drug | In the first year, the trial granules will be started after enrollment for 3 months; In the second year, the trial granules will be started in the first 3 months; Each participant should have completed 6 months of trial granules. |
| Measure | Description | Time Frame |
|---|---|---|
| Adenoma detection rate | The ratio of the number of patients with new adenoma detected by colonoscopy to the total number of cases in this group during follow-up. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| The detection rate of any polypoid lesions | The ratio of the number of patients with any polypoid lesions detected by colonoscopy to the total number of cases in this group during follow-up. | 2 years |
| The detection rate of high-risk adenomas |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chen Yugen, PhD | Key members of the study | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Nanjing University of TCM | Nanjing | Jiangsu | 210029 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31374049 | Derived | Zhou Q, Chen YG, Xiao J, Chen TT, Liu JR, Zhou W, Li WZ, Wang Y, Zhang BP, Lin J, Meng FD, Gong B, Zheng GY, Han ST, Cheng HB. Traditional Chinese medicine (Xiaoai Jiedu Decoction) as an adjuvant treatment for prevention new colorectal adenomatous polyp occurrence in post-polypectomy: Study protocol for a randomized controlled trial. Medicine (Baltimore). 2019 Aug;98(31):e16680. doi: 10.1097/MD.0000000000016680. |
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The data supporting the findings of this study are restricted in availability due to patient confidentiality reasons.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 16, 2021 | Nov 9, 2023 | Prot_SAP_000.pdf |
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| ShuGuang Hospital | OTHER |
| The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine | OTHER |
| Changhai Hospital | OTHER |
| Beijing Friendship Hospital | OTHER |
| The First Affiliated Hospital with Nanjing Medical University | OTHER |
| West China Hospital | OTHER |
colorectal adenomatous polyp patients after colonoscopy under colonoscopy
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A double-blind design is used in this study for the investigators and subjects. The blinding codes are separately sealed and stored by the independent third-party organization. Trial granules are randomly coded as subject unique identification codes, and used by each clinical site according to the assigned drug numbers and in the order of case enrollment. Clinical monitors and investigators must be blinded at all times.
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The ratio of the number of patients with high-risk adenomas detected by colonoscopy to the total number of cases in this group during follow-up.
| 2 years |
| The detection rate of sessile serrated lesions | The ratio of the number of patients with sessile serrated lesions detected by colonoscopy to the total number of cases in this group during follow-up. | 2 years |