AzTrials
AzTrials

Colorectal AdenomaPhase 2/3NCT02226185

Study of Berberine Hydrochloride in Prevention of Colorectal Adenomas Recurrence

A Phase 2/3 study testing Berberine hydrochloride in people with Colorectal Adenoma, run by Shanghai Jiao Tong University School of Medicine at 7 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Colorectal Adenoma
What is being tested?
Berberine hydrochloride
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,108 participants
Where
7 sitesChina
Study dates
Nov 2014to 29 Dec 2018
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 15Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

China7 sites

  • Department of Gastroenterology, the Seventh Medical Center of PLA General Hospital

    Beijing, Beijing Municipality

  • Department of Gastroenterology, Nanfang Hospital, Southern Medical Univerisity

    Guangdong, Guangzhou

  • Division of Gastroenterology and Hepatology, The Affiliated DrumTower of Nanjing University Medical School

    Nanjing, Jiangsu

  • 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

  • Department of Gastroenterology, the Shanghai Tenth People's Hospital, Tongji University

    Shanghai, Shanghai Municipality

  • Department of Gastroenterology and Hepatology, General Hospital, Tianjin Medical University

    Tianjin, Tianjin Municipality

  • Department of Gastroenterology, Zhongshan Hospital, Xiamen University

    Xiamen, Fujian

Other trials in China

About this study

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

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.

Read the detailed 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.

Being tested
Berberine hydrochloride, placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Berberine hydrochlorideDrug

    supplement of Berberine hydrochloride 0.3g two times per day for 2-3 years

  • placeboDrug

    supplement of placebo two times per day for 2-3 years

Study groups in NCT02226185
Study groupRoleWhat they receive
Berberine hydrochlorideExperimentalsupplement of Berberine hydrochloride 0.3g two times per day for 2-3 years
Receives: Drug: Berberine hydrochloride
placeboPlacebo comparatoridentical-appearing placebo supplements for 2-3 years
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: until the last patient reached the 2 years follow-up

Secondary outcomes (1)

  1. 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

    Measured: until the last patient reached the 2 years follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2014 (estimated)
  2. Study startNov 2014
  3. Primary completion29 Dec 2018
  4. Study completion29 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
1,108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02226185
Sponsor's protocol ID
RJ2014BH
Status last verified
Mar 2019
First submitted
23 Aug 2014
Last updated
26 Mar 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 37553874

  • 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.

    PubMed 31926918

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Berberine hydrochloride in people with Colorectal Adenoma, run by Shanghai Jiao Tong University School of Medicine at 7 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence rates of CRA (time frame: until the last patient reached the 2 years follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02226185, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in