Clinical Trial to Evaluate the Efficacy and Safety of 'URSA SOFT CAP. (UDCA-003)' in Fatigue Patients With Liver Dysfunction

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.
• Treatments: Riboflavin; Thiamine; Ursodeoxycholic Acid

Criteria

Inclusion Criteria:

• CIS greater than or equal to 76, HADS less than or equal to 10

• ALT greater than upper limit of normal OR fatty liver on US

Exclusion Criteria:

• Subjects who have diseases that can cause fatigue

• Subjects who are taking medication that can cause fatigue