Study of Berberine Hydrochloride in Prevention of Colorectal Adenomas Recurrence

Colorectal Adenoma Clinical Trial

Official title:

A Randomized, Placebo-controlled, Multicenter, Prospective Clinical Study of Berberine Hydrochloride in Preventing Recurrence and Carcinogenesis After Endoscopic Removal of Colorectal Adenomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02226185
• Other study ID #: RJ2014BH
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: November 2014
• Est. completion date: December 29, 2018

Study information

• Verified date: March 2019
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1108
• Est. completion date: December 29, 2018
• Est. primary completion date: December 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion criteria

• Individuals aged 18-75 years

• Individuals who had at least one and no more than 6 histologically confirmed CRAs removed within 6 months before recruitment

• Individuals who are able to swallow pills

• Individuals who voluntarily sign the consent form after being fully informed and understanding the purpose and procedure of this study, characters of the disease, effect of medication, methods of related examinations, and potential risk/benefits of the study 4.2 Exclusion criteria

• Individuals whose adenoma was not completely removed during previous colonoscopy

• Individuals with a history of familial adenomatous polyposis (FAP) or hereditary non-polyposis colorectal cancer (HNPCC, Lynch syndrome)

• Individuals who are taking regularly aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), cyclo-oxygenase 2 (COX2) inhibitors, calcium or vitamin D

• Individuals with a history of subtotal/total gastrectomy or partial bowel resection

• Individuals who are intolerant to another colonoscopy examination

• Individuals who are hypersensitive or intolerant to the drugs

• Individuals with severe heart, liver or kidney disease, or any cancer history

• Individuals presenting severe constipation

• Pregnant women, women during breast-feeding period, or women with expect pregnancy

• Individuals with mental diseases who are not able to cooperate

• Individuals who are involved in designing, planning or performing this trial

Related Conditions & MeSH terms

• Adenoma
• Colorectal Adenoma
• Recurrence

Intervention

Drug:
• Berberine hydrochloride
supplement of Berberine hydrochloride 0.3g two times per day for 2-3 years
• placebo
supplement of placebo two times per day for 2-3 years

Locations

Country	Name	City	State
China	Department of Gastroenterology, the Seventh Medical Center of PLA General Hospital	Beijing	Beijing
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	Department of Gastroenterology, the Shanghai Tenth People's Hospital, Tongji University	Shanghai	Shanghai
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
China	Department of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University	Tianjin	Tianjin
China	Department of Gastroenterology, Zhongshan Hospital, Xiamen University	Xiamen	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in fecal microflora	Fecal microflora tests	baseline, the 1st year and the 2nd year
Primary	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
Secondary	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