The objective of this clinical trial is to evaluate the efficacy and safety of CnU capsule 750 mg administration in patients with Cholesterol gallstone (radiolucent gallstones)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
484
CnU capsule(Magnesium Salt Trihydrate of Chenodeoxycholic Acid and Ursodeoxycholic Acid) and Ursa placebo tablet will be orally administered three times a day after meals at regular intervals for a total of 24 weeks.
Ursa tablet(Ursodeoxycholic Acid) and CnU placebo capsule will be orally administered three times a day after meals at regular intervals for a total of 24 weeks.
Korea University Ansan Hospital
Ansan, Gyeonggi-do, South Korea
RECRUITINGSoonchunhyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, South Korea
Response to dissolution therapy
Response to dissolution therapy at 24 weeks compared to baseline in patients with Cholesterol gallstones. The dissolution response rate is defined as the sum of the GB stones complete and partial dissolution rates.
Time frame: From baseline to the end of treatment at 24 weeks
1) GB stones complete dissolution rate 2) GB stones partial dissolution rate 3) GB stones dissolution rate
1. GB stones complete dissolution rate: The complete GB stones dissolution rate is defined as the proportion of subjects with no detectable gallbladder stones on ultrasonography. 2. GB stones partial dissolution rate: The partial GB stones dissolution rate is defined as the proportion of subjects who show a reduction of more than 50% in GB stones volume. 3. GB stones dissolution rate: The GB stones dissolution rates are defined as the rate of reduction in GB stones volume and the area of gallbladder sludge as measured by ultrasonography.
Time frame: From baseline to the end of treatment at 24 weeks
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Ajou University Hospital
Suwon, Gyeonggi-do, South Korea
RECRUITINGPusan National University Hospital
Busan, South Korea
RECRUITINGKyungpook National University Hospital
Daegu, South Korea
RECRUITINGCHA Bundang Medical Center
Gyeonggi-do, South Korea
RECRUITINGHallym University Dongtan Sacred Heart Hospital
Gyeonggi-do, South Korea
RECRUITINGSoonchunhyang University Cheonan Hospital
Gyeonggi-do, South Korea
RECRUITINGInha University Hospital
Incheon, South Korea
RECRUITINGInje University Sanggye Paik Hospital
Seoul, South Korea
RECRUITING...and 3 more locations