Back to resultsA 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.
Primary Purpose
Fatigue
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ursodeoxycholic acid, taurine, ginsenoside, thiamine, inositol
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Fatigue
Eligibility Criteria
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
Sites / Locations
- Seoul St. Mary's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
UDCA004
Placebo of UDCA004
Arm Description
UDCA004
Placebo of UDCA004
Outcomes
Primary Outcome Measures
Rate of subjects whose CIS score has improved under 76 at week 4
Secondary Outcome Measures
Full Information
NCT ID
NCT02418130
First Posted
October 8, 2014
Last Updated
April 15, 2015
Sponsor
Daewoong Pharmaceutical Co. LTD.
1. Study Identification
Unique Protocol Identification Number
NCT02418130
Brief Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewoong Pharmaceutical Co. LTD.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
166 (Actual)
8. Arms, Groups, and Interventions
Arm Title
UDCA004
Arm Type
Experimental
Arm Description
UDCA004
Arm Title
Placebo of UDCA004
Arm Type
Placebo Comparator
Arm Description
Placebo of UDCA004
Intervention Type
Drug
Intervention Name(s)
Ursodeoxycholic acid, taurine, ginsenoside, thiamine, inositol
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Rate of subjects whose CIS score has improved under 76 at week 4
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
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.
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