A Study to Evaluate the Efficacy and Safety of CnU Capsule 750 mg in Patients With Cholesterol Gallstones(GB Stones).

Multi-center, Randomized, Double-blind, Active Controlled, Parallel Clinical Trial for the Evaluation of the Efficacy and Safety of CnU Cap. 750 mg in Patients With Cholesterol Gallstone

NCT07005752•Myungmoon Pharma. Co. Ltd.

View on ClinicalTrials.gov

Summary

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)

Eligibility

Age

19 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Individuals who have voluntarily agreed to participate in this clinical trial
•2. Adults aged 19 years and older
•3. Individuals diagnosed with gall bladder stone(GB stone) with a maximum diameter size of 15 mm or less, as determined by abdominal ultrasonography at the screening stage, and who have radiolucent GB stones on plain abdominal X-ray

Exclusion Criteria

•1\. Medical History
•1. Patients with frequent biliary colic or biliary infections (severe pancreatic changes, such as ileal resection, resection surgery, or partial ileitis, may alter the composition of bile acids circulating in the intestines).
•2. Patients with obstructive jaundice.
•3. Patients with liver disease.
•4. Patients with severe kidney disease.
•5. Patients with severe biliary obstruction (due to choleretic effects, symptoms may worsen).
•6. Patients with underlying diseases that could worsen biliary obstruction (such as biliary cancer, cholangitis, or biliary cysts).
•7. Patients with acute cholecystitis.
•8. Patients with peptic ulcers (due to mucosal irritation, symptoms may worsen).
•9. Patients with inflammatory bowel diseases, such as Crohn's disease.
+29 more criteria

Locations (6)

Pusan National University Hospital

Busan, South Korea

CHA Bundang Medical Center

Gyeonggi-do, South Korea

Hallym University Dongtan Sacred Heart Hospital

Gyeonggi-do, South Korea

Soonchunhyang University Cheonan Hospital

Gyeonggi-do, South Korea

Inha University Hospital

Incheon, South Korea

Gangnam Severance Hospital

Seoul, South Korea

Key Dates

Start Date

July 28, 2025

Primary Completion Date

June 1, 2026

Completion Date

June 1, 2026

Last Updated

October 2, 2025

Enrollment

484

ESTIMATED participants

Conditions

Cholesterol Cholelithiasis

Interventions

CnU cap. 250mg & Ursa placebo tab. 200mg

DRUG

Ursa tab. 200mg & CnU placebo cap. 250mg

DRUG