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The effect of Stain with Ezetimibe for adjunctive therapy of Ursodeoxycholic acid for dissolution of cholesterol gallstones: prospective, randomized, comparative study

The effect of Stain with Ezetimibe for adjunctive therapy of Ursodeoxycholic acid for dissolution of cholesterol gallstones: prospective, randomized, comparative study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0001517
Enrollment
380
Registered
2015-06-09
Start date
2014-09-05
Completion date
Unknown
Last updated
2019-03-11

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

Conditions

None listed

Interventions

None listed

Sponsors

The Catholic University of Korea, St. Vincent's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) older than 19 years 2) cholelithiasis confirmed by ultrasonography with dysplidemia 3) not combined with severe complication such as acute cholecystitis, cholangitis, or pancreatitis - no fever (below 37.5'c) - no leuckocytosis - no elevation of serum bilirubin 4) having gallbladder symptoms (RUQ or upper abdominal pain over 30 minutes) * Patients in control group should not have dyslipidemia.

Exclusion criteria

Exclusion criteria: 1) size of gallstone = 15mm, presense of calcification 2) Body mass index = 35kg/m-2 3) severe or frequent abdominal pain 4) nonfunctioning gallbladder 5) previous treatment of hydrophilic bile acid 6) abnormal liver function test over 4 weeks 7) abuse or dependence of drugs or alcohol 8) history of antibiotics within 3 months 9) presence of gastrointestinal cancer which can caused obstruction 10) history of gastrointestinal surgery 11) presence of gastrointestinal diseases such as ulcers 12) renal insufficiency; liver diseases 13) current use of narcotics, probiotics, or antidiarrheal drugs 14) hearing impairment 15) pregnancy or breast feeding

Design outcomes

Primary

MeasureTime frame
type, size and number of gallstones before and after treatment

Secondary

MeasureTime frame
symptoms of patients before and after treatment;complications associated with gallstones during treatment;cholecystectomy due to aggravation of symptoms or complications during treatment

Countries

Korea, Republic of

Contacts

Public ContactChang-Nyol Paik

The Catholic University of Korea, St. Vincent's Hospital

Outcome results

None listed

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