A Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of 'Ursa Complex Soft Cap. (UDCA-004)' in Patients With Physical Fatigue.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02418130

Enrollment

166

Registered

2015-04-16

Start date

2014-10-31

Completion date

2015-03-31

Last updated

2015-04-16

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 Complex Soft Cap. (UDCA-004)' in patients with physical fatigue.

Interventions

DRUGUrsodeoxycholic acid, taurine, ginsenoside, thiamine, inositol

DRUGPlacebo

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

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 4	4 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026