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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CnU capsule 250 mg(1 capsule) and Ursa placebo tablet 200 mg(1 tablet) | Experimental |
| |
| Ursa tablet 200 mg(1 tablet) and CnU placebo capsule 250 mg(1 capsule) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CnU cap. 250mg & Ursa placebo tab. 200mg | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to the end of treatment at 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 1) GB stones complete dissolution rate 2) GB stones partial dissolution rate 3) GB stones dissolution rate |
|
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Inclusion Criteria:
Exclusion Criteria:
1. Medical History
2. Individuals showing abnormal test results at the screening stage:
3. Contraindicated drugs and therapies
The following drugs may be used after a washout period and registration:
The following drugs cannot be used regardless of the washout period: Alpha-methyldopa.
4. Pregnant and breastfeeding women
5. Contraception
Participants and their spouses (or partners) who do not use medically acceptable contraceptive methods throughout the clinical trial period:
6. Other individuals deemed inappropriate for participation in the clinical trial by the investigator.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan National University Hospital | Recruiting | Busan | South Korea |
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| Ursa tab. 200mg & CnU placebo cap. 250mg | Drug | 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. |
|
| From baseline to the end of treatment at 24 weeks |
| CHA Bundang Medical Center | Recruiting | Gyeonggi-do | South Korea |
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| Hallym University Dongtan Sacred Heart Hospital | Recruiting | Gyeonggi-do | South Korea |
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| Soonchunhyang University Cheonan Hospital | Recruiting | Gyeonggi-do | South Korea |
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| Inha University Hospital | Recruiting | Incheon | South Korea |
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| Gangnam Severance Hospital | Recruiting | Seoul | South Korea |
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