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A multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of 'URSA SOFT CAP. (UDCA-003)' in fatigue patients with liver dysfunction
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| udca003 | Experimental | udca003 |
|
| placebo | Placebo Comparator | placebo of udca003 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ursodeoxycholic acid, thiamine, riboflavin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of subjects whose CIS score has improved under 76 at week 8 | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ilsan Paik Hospital | Ilsan | Kyung-gi-do | 411-706 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26997458 | Derived | Oh B, Choi WS, Park SB, Cho B, Yang YJ, Lee ES, Lee JH. Efficacy and safety of ursodeoxycholic acid composite on fatigued patients with elevated liver function and/or fatty liver: a multi-centre, randomised, double-blinded, placebo-controlled trial. Int J Clin Pract. 2016 Apr;70(4):302-11. doi: 10.1111/ijcp.12790. Epub 2016 Mar 20. |
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| ID | Term |
|---|---|
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D014580 | Ursodeoxycholic Acid |
| D013831 | Thiamine |
| D012256 | Riboflavin |
| ID | Term |
|---|---|
| D003840 | Deoxycholic Acid |
| D002793 | Cholic Acids |
| D001647 | Bile Acids and Salts |
| D013256 | Steroids |
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| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002757 | Cholanes |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D005415 | Flavins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |