NCT02418130

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
166

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2014

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

October 8, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 16, 2015

Completed
Last Updated

April 16, 2015

Status Verified

April 1, 2015

Enrollment Period

5 months

First QC Date

October 8, 2014

Last Update Submit

April 15, 2015

Conditions

Fatigue

Outcome Measures

Primary Outcomes (1)

  • Rate of subjects whose CIS score has improved under 76 at week 4

    4 weeks

Study Arms (2)

UDCA004

EXPERIMENTAL

UDCA004

Drug: Ursodeoxycholic acid, taurine, ginsenoside, thiamine, inositol

Placebo of UDCA004

PLACEBO COMPARATOR

Placebo of UDCA004

Drug: Placebo

Interventions

Ursodeoxycholic acid, taurine, ginsenoside, thiamine, inositolDRUG
UDCA004
PlaceboDRUG
Placebo of UDCA004

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Subjects who have diseases that can cause fatigue
  • Subjects who are taking medication that can cause fatigue

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul St. Mary's Hospital

Seoul, Seoul, 137-701, South Korea

Location

MeSH Terms

Conditions

Fatigue

Interventions

Ursodeoxycholic AcidTaurineGinsenosidesThiamineInositol

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Deoxycholic AcidCholic AcidsBile Acids and SaltsSteroidsFused-Ring CompoundsPolycyclic CompoundsCholanesAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsSulfonic AcidsSulfur AcidsSulfur CompoundsTriterpenesTerpenesSaponinsGlycosidesCarbohydratesThiazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidinesSugar AlcoholsAlcohols

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2014

First Posted

April 16, 2015

Study Start

October 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

April 16, 2015

Record last verified: 2015-04

Locations

KR(1)