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

Daewoong Pharmaceutical

Status and phase: Completed; Phase 4

Conditions: Fatigue

Treatments: Drug: Ursodeoxycholic acid, thiamine, riboflavin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02415777

DW_UDCA003

Details and patient eligibility

About

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

Enrollment: 168 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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168 participants in 2 patient groups, including a placebo group

udca003

Experimental group

Description:

udca003

Treatment:

Drug: Ursodeoxycholic acid, thiamine, riboflavin

placebo

Placebo Comparator group

Description:

placebo of udca003

Treatment:

Drug: Ursodeoxycholic acid, thiamine, riboflavin