None listed
Conditions
Interventions
Drug : single : ursodeoxycholic acid
combination : ursodioxycholic acid and N-3 polyunsaturated fatty acids
Sponsors
Yonsei University Health System, Gangnam Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • over 19 years old • Patients with abdominal ultrasonographic gallbladder gallstones • Patients whose gallbladder gallstones are less than 15 mm on ultrasound • Patients without visible gallbladder gallstones on abdominal simple X-ray • Patients with no or mild symptoms from gallbladder gallstones • Patients with mild symptoms are defined as follows (all three conditions must be met) :• intensity of pain: less than 5 on visual analogue scale • frequency of pain: less than 3 times a week• Duration of pain: less than 30 minutes • Patients who can follow the protocol of the clinical trial and can take oral medications • You can hear the full explanation and sign the agreement. • Have not received any other investigational drug within 30 days prior to screening • A woman of childbearing potential must be negative on a pregnancy test done within 7 days of the first dose of test medication. Women who are of childbearing potential, as well as men, agree to use the appropriate contraceptive method prior to entering the trial and during the study period, including the 30-day period following the last dose of study drug.
Exclusion criteria
Exclusion criteria: • Patients with moderate to severe symptoms caused by gallbladder gallstones • Patients with moderate to severe symptoms are defined as follows (must meet at least one of the three conditions below): • intensity of pain: 5 or more on visual analogue scale • frequency of pain: at least three times a week • Duration of pain: more than 30 minutes • Patients who underwent gastrointestinal surgery • Gallbladder tumor patients • Patients with jaundice • Women who are pregnant or breastfeeding. • unstable or in a condition that could put the subject at risk or compromise the subject's compliance • Subjects who cannot swallow oral medications or all malabsorption conditions • Patients with hypersensitivity to urdeoxycholic acid • Patients with hypersensitivity to omega 3-acid ethyl ester • Complete biliary obstruction • patients with acute cholecystitis • severe hepatitis patients • Nonfunctional gallbladder patients • Radiopaque calcified gallstone patients • patients with kidney disease Peptic ulcer patients • Patients with colon and colitis such as Crohn's disease • Patients with genetic problems such as galactose intolerance, Lapp lactose deficiency, or glucose galactose malabsorption • Patients taking combination contraindications 1) Oral diabetics (eg tolbutamide) 2) Antacids containing cholestyramine, cholestipol, medicinal charcoal, magnesium and aluminum hydroxide 3) Drugs that reduce cholesterol in bile (biliary bile) (e.g. oral contraceptives containing estrogen) or drugs that reduce cholesterol in the blood (e.g. clopibret) 4) drugs that damage the liver 5) Anticoagulants (oxalate, citrate, warfarin, heparin) 6) Acetylsalicylic Acid (Aspirin) • Any other serious systemic disease that the Investigator deems unsuitable to conduct the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of gallstone dissolution effect of ursodeoxycholic acid single administration group and ursodeoxycholic acid with N-3 polyunsaturated fatty acids combination group in patients with gallbladder | — |
Secondary
| Measure | Time frame |
|---|---|
| The frequency and pain level of clinical symptoms of gallbladder gallstone, the incidence rate of cystitis | — |
Countries
Korea, Republic of
Contacts
Public ContactSung Iil Jang
Yonsei University Health System, Gangnam Severance Hospital
Outcome results
None listed