Clinical research on the efficacy of CNU in dissolving gallstones and improving gallstone-related symptom.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0000996

Enrollment

220

Registered

2014-01-29

Start date

2011-01-24

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

Drug : 1.name:CnU capsule 2.content: magnesium trihydrate salt 22mg,chenodexoycholic acid 114mg, ursodeoxycolic acid 114mg 3.administration:1 capsule in the morning, 2 capsule before going bed 4.durat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Sonographically defined GB stone(diameter<15mm) 2. Stones are radiolucent on Plain X-ray. 3. GB EF = 50% in DICIDA biliary scan

Exclusion criteria

Exclusion criteria: 1. patients with complicated GB stone such as acute cholecystitis. 2. high degree obese person (BMI>35kg/m2) 3. obstructive jaundice or CBD stone 4. liver disease(Abnormal LFT ( ALT >2x N)), liver cirrhosis 5. renal insufficiency 6. hyperesensitivity to bile acid 7. pregnancy or breast feeding women 8. malignancy 9. Patents with GI operation Hx 10. GB ejection fraction <50% or nonvisualization of GB

Design outcomes

Primary

Measure	Time frame
Absence of GB stone in sonography;The change of diameter of largest GB stone in sonography	—

Secondary

Measure	Time frame
Measurement of VAS related with GB stone related symptom according to treatment;adverse effect of CNU treatment	—

Countries

Korea, Republic of

Contacts

Public ContactLEE SIK

Korea University Anam Hospital

Outcome results