NCT03281096

A Research of Berberine Hydrochloride to Prevent Colorectal Adenomas in Patients With Previous Colorectal Cancer

Completed Phase 2, PHASE3 Last updated 27 July 2022

What this trial tests

Phase 2, PHASE3 trial testing Berberine hydrochloride in Colorectal Adenomas in 1,000 participants. Completed in 1 March 2021.

Timeline

29 August 2017

Primary endpoint
12 October 2020

1 March 2021

Quick facts

Lead sponsor	Xijing Hospital of Digestive Diseases
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	1,000
Start date	29 August 2017
Primary completion	12 October 2020
Estimated completion	1 March 2021
Sites	1 location across China

Drugs / interventions tested

• Berberine hydrochloride — full drug profile →
• Placebo

Conditions studied

• Colorectal Adenomas — all drugs for Colorectal Adenomas →

Sponsor

Xijing Hospital of Digestive Diseases

Who can join

Adults 18 to 80, any sex, with Colorectal Adenomas. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Experimental studies in animals and observational studies in humans suggest that fusobacterium nucleatum is associates with stages of colorectal neoplasia development, and Berberine Hydrochloride could rescue Fusobacterium nucleatum-induced colorectal tumorigenesis by modulating the tumor microenvironment. Whether regular Berberine Hydrochloride use may decrease the risk of colorectal adenomas, the precursors to most colorectal cancers is worth to further study.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Phytochemicals in Cancer Treatment: From Preclinical Studies to Clinical Practice.
   Choudhari AS, Mandave PC, Deshpande M, Ranjekar P, et al · · 2019 · cited 560× · PMID 32116665 · DOI 10.3389/fphar.2019.01614
2. Overcoming cancer therapeutic bottleneck by drug repurposing.
   Zhang Z, Zhou L, Xie N, Nice EC, et al · · 2020 · cited 328× · PMID 32616710 · DOI 10.1038/s41392-020-00213-8
3. Natural Products as Anticancer Agents: Current Status and Future Perspectives.
   Naeem A, Hu P, Yang M, Zhang J, et al · · 2022 · cited 292× · PMID 36500466 · DOI 10.3390/molecules27238367
4. Unlocking hidden potential: advancements, approaches, and obstacles in repurposing drugs for cancer therapy.
   Weth FR, Hoggarth GB, Weth AF, Paterson E, et al · · 2024 · cited 112× · PMID 38012383 · DOI 10.1038/s41416-023-02502-9
5. Nano-Drug Delivery Systems Entrapping Natural Bioactive Compounds for Cancer: Recent Progress and Future Challenges.
   Chavda VP, Patel AB, Mistry KJ, Suthar SF, et al · · 2022 · cited 75× · PMID 35425710 · DOI 10.3389/fonc.2022.867655
6. Berberine and Obatoclax Inhibit SARS-Cov-2 Replication in Primary Human Nasal Epithelial Cells In Vitro.
   Varghese FS, van Woudenbergh E, Overheul GJ, Eleveld MJ, et al · · 2021 · cited 52× · PMID 33670363 · DOI 10.3390/v13020282
7. Natural Nrf2 Inhibitors: A Review of Their Potential for Cancer Treatment.
   Zhang J, Xu HX, Zhu JQ, Dou YX, et al · · 2023 · cited 49× · PMID 37416770 · DOI 10.7150/ijbs.82401
8. Modulation of the tumor microenvironment by natural agents: implications for cancer prevention and therapy.
   Zubair H, Khan MA, Anand S, Srivastava SK, et al · · 2022 · cited 44× · PMID 32470379 · DOI 10.1016/j.semcancer.2020.05.009