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Study on the effect of berberine hydrochloride in the treatment of familial patients with familial adenomatous polyposis

Randomized, double blind, placebo-controlled study of berberine hydrochloride in the treatment of familial adenomatous polyposis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-15007227
Enrollment
Unknown
Registered
2015-10-12
Start date
2015-11-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

familial adenomatous polyposis

Interventions

2:Berberine hydrochloride
3:Celecoxib
4:Berberine hydrochloride combined with celecoxib

Sponsors

The Military General Hospital of Beijing PLA
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: The trial population was patients with FAP, defined as the presence of 100 adenomas in the large intestine, or a germline mutation in the adenomatous polyposis coli (APC) gene. All the subjects participating in the trial were aged >18 and <60 years,and did not accepted colectomy. FAP patients had received colonoscopy regularly and already had polyps 10mm or larger removed endoscopically, and did Not taken antibiotics, calcium, corticosteroids and other non steroidal anti-inflammatory drugs in the first 3 months of the group.

Exclusion criteria

Exclusion criteria: The following were excluded from the trial: (1) patients with active cancer at the time of entry; (2) those with Severe constipation; (3) individuals with a history of stroke or gastric/duodenal ulcers; (4) those with bleeding tendency; (5) those with abnormal prothrombin time; (6) people with known allergy to berberine hydrochloride; (7) those who were pregnant or planned to become pregnant during the trial period, and (8) those taking an NSAID, COX-2 inhibitors or calcium.

Design outcomes

Primary

MeasureTime frame
The number and size of the total number of high-risk adenomas in the whole colon;The number and size of 5cm in the rectum from the dentate line;The changes of microbial population, diversity and distribution of intestinal microflora in the feces;The changes of microbial population, diversity and distribution of intestinal microflora in the colon tissue;

Countries

China

Contacts

Public ContactLi Na
lina200481@163.com+86 15011158690

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026