A Phase 2/3 interventional study of Berberine hydrochloride and placebo in Colorectal Adenoma, sponsored by Shanghai Jiao Tong University School of Medicine. Completed at 7 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-03-26.
Sponsored by Shanghai Jiao Tong University School of Medicine · Phase 2/3, Interventional, and Prevention
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.
657 studies on the registry are indexed under Adenoma; 98 are open to participants now.
This study's enrollment of 1,108 is above the median of 250 across 412 interventional studies indexed under Adenoma.
Browse Adenoma studies →Shanghai Jiao Tong University School of Medicine is the lead sponsor of 358 studies on the registry; 104 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria
supplement of Berberine hydrochloride 0.3g two times per day for 2-3 years
Drug: Berberine hydrochloride
identical-appearing placebo supplements for 2-3 years
Drug: placebo
supplement of Berberine hydrochloride 0.3g two times per day for 2-3 years
supplement of placebo two times per day for 2-3 years
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.
Time frame: until the last patient reached the 2 years follow-up
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
Time frame: until the last patient reached the 2 years follow-up
Changes in fecal microflora
Fecal microflora tests
Time frame: baseline, the 1st year and the 2nd year
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This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Shanghai Jiao Tong University School of Medicine