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Berberine hydrochloride is a conventional component in Chinese medicine. In recent years, anticancer activity of berberine hydrochloride have been explored. The aim of this study is to investigate the effect of berberine hydrochloride on the recurrence of colorectal adenomas.
Colorectal adenomas are well-known to be precancerous lesions that develop into colorectal cancers on the basis of the adenoma-carcinoma sequence. The effects of screening for colorectal adenomas and removing precancerous lesions on the prevention of colorectal cancer have been established. Because of the high recurrence rates of colorectal adenomas in patients who have undergone polypectomy, the potential chemopreventive agents that may reduce the risk of colorectal adenoma recurrence need to be investigated.
Berberine hydrochloride is a conventional component in Chinese medicine. In recent years, anticancer activity of berberine hydrochloride have been explored. The aim of this study is to investigate the effect of berberine hydrochloride on the recurrence of colorectal adenomas by conducting a randomized, placebo-controlled, prospective clinical.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Berberine hydrochloride | Experimental | supplement of Berberine hydrochloride 0.3g two times per day for 2-3 years |
|
| placebo | Placebo Comparator | identical-appearing placebo supplements for 2-3 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Berberine hydrochloride | Drug | supplement of Berberine hydrochloride 0.3g two times per day for 2-3 years |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence rates of CRA | The primary objective of this study is to investigate recurrence rates of colorectal adenoma (CRA) after Berberine hydrochloride or placebo intervention. | until the last patient reached the 2 years follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of all polypoid lesions or advanced colorectal adenoma or colorectal cancer | The incidence of all polypoid lesions or advanced colorectal adenoma or colorectal cancer after Berberine hydrochloride or placebo intervention | until the last patient reached the 2 years follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in fecal microflora | Fecal microflora tests | baseline, the 1st year and the 2nd year |
Inclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Jing-Yuan Fang, M.D., Ph.D | Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastroenterology, the Seventh Medical Center of PLA General Hospital | Beijing | Beijing Municipality | China | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37553874 | Derived | Qian Y, Kang Z, Zhao L, Chen H, Zhou C, Gao Q, Wang Z, Liu Q, Cui Y, Li X, Chen Y, Zou T, Fang J. Berberine might block colorectal carcinogenesis by inhibiting the regulation of B-cell function by Veillonella parvula. Chin Med J (Engl). 2023 Nov 20;136(22):2722-2731. doi: 10.1097/CM9.0000000000002752. Epub 2023 Aug 9. | |
| 31926918 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 12, 2020 | |
| Reset | Dec 8, 2020 |
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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 | Dec 22, 2018 | Mar 13, 2019 | Prot_SAP_001.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 12, 2020 | Dec 8, 2020 |
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| placebo | Drug | supplement of placebo two times per day for 2-3 years |
|
| Department of Gastroenterology, Zhongshan Hospital, Xiamen University |
| Xiamen |
| Fujian |
| China |
| Department of Gastroenterology, Nanfang Hospital, Southern Medical Univerisity | Guangdong | Guangzhou | China |
| Division of Gastroenterology and Hepatology, The Affiliated DrumTower of Nanjing University Medical School | Nanjing | Jiangsu | China |
| Division of Gastroenterology and Hepatology, Ren-Ji Hospital, Shanghai Jiao-Tong University School of Medicine, Shanghai Institute of Digestive Disease; Key Laboratory of Gastroenterology & Hepatology, Ministry of Health | Shanghai | Shanghai Municipality | 200001 | China |
| Department of Gastroenterology, the Shanghai Tenth People's Hospital, Tongji University | Shanghai | Shanghai Municipality | China |
| Department of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University | Tianjin | Tianjin Municipality | China |
| Chen YX, Gao QY, Zou TH, Wang BM, Liu SD, Sheng JQ, Ren JL, Zou XP, Liu ZJ, Song YY, Xiao B, Sun XM, Dou XT, Cao HL, Yang XN, Li N, Kang Q, Zhu W, Xu HZ, Chen HM, Cao XC, Fang JY. Berberine versus placebo for the prevention of recurrence of colorectal adenoma: a multicentre, double-blinded, randomised controlled study. Lancet Gastroenterol Hepatol. 2020 Mar;5(3):267-275. doi: 10.1016/S2468-1253(19)30409-1. Epub 2020 Jan 8. |