Actively Recruiting
A Study to Evaluate the Efficacy and Safety of CnU Capsule 750 mg in Patients With Cholesterol Gallstones(GB Stones).
Led by Myungmoon Pharma. Co. Ltd. · Updated on 2025-10-02
484
Participants Needed
6
Research Sites
44 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
A Study to Evaluate the Efficacy and Safety of CnU Capsule 750 mg in Patients With Cholesterol Gallstones(GB Stones).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals who have voluntarily agreed to participate in this clinical trial
- Adults aged 19 years and older
- Diagnosed with gallbladder stone 15 mm or smaller by ultrasound and radiolucent gallstones on X-ray
You will not qualify if you...
- History of frequent biliary colic or biliary infections
- Obstructive jaundice
- Liver disease
- Severe kidney disease
- Severe biliary obstruction or underlying diseases worsening biliary obstruction
- Acute cholecystitis
- Peptic ulcers
- Inflammatory bowel diseases such as Crohn's disease
- Cholestasis
- Abnormal gallbladder contraction
- Malignant tumor history within 5 years
- History of gastrointestinal surgery
- Hypersensitivity to study drug ingredients
- Clinically significant cardiovascular, gastrointestinal, respiratory, endocrine, or central nervous system disorders
- Mental disorders affecting trial participation
- Drug or alcohol addiction
- Genetic disorders like galactose intolerance or lactase deficiency
- BMI 35 kg/m² or higher
- Abnormal liver function tests (ALT, AST, bilirubin)
- Reduced kidney function (eGFR < 60 mL/min/1.73 m²)
- Positive serum tests for hepatitis B, C, HIV, or syphilis
- Use of contraindicated medications within specified washout periods
- Use of alpha-methyldopa
- Pregnant or breastfeeding women
- Lack of medically acceptable contraception during the trial
- Other conditions deemed inappropriate by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Pusan National University Hospital
Busan, South Korea
Actively Recruiting
2
CHA Bundang Medical Center
Gyeonggi-do, South Korea
Actively Recruiting
3
Hallym University Dongtan Sacred Heart Hospital
Gyeonggi-do, South Korea
Actively Recruiting
4
Soonchunhyang University Cheonan Hospital
Gyeonggi-do, South Korea
Actively Recruiting
5
Inha University Hospital
Incheon, South Korea
Actively Recruiting
6
Gangnam Severance Hospital
Seoul, South Korea
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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