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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02415777

Enrollment

168

Registered

2015-04-14

Start date

2014-10-31

Completion date

2015-07-31

Last updated

2016-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatigue

Brief 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

Interventions

DRUGUrsodeoxycholic acid, thiamine, riboflavin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Rate of subjects whose CIS score has improved under 76 at week 8	8 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026