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NCT02418130 Clinical 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.

Fatigue Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02418130
Other study ID # DW_UDCA004
Secondary ID
Status Completed
Phase Phase 4
First received October 8, 2014
Last updated April 15, 2015
Start date October 2014
Est. completion date March 2015

Study information
Verified date April 2015
Source Daewoong Pharmaceutical Co. LTD.
Contact n/a
Is FDA regulated No
Health authority Ministry of Food and Drug Safety: Korea
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 166
Est. completion date March 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Both
Age group 19 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

• Placebo

Locations
Country Name City State
Korea, Republic of Seoul St. Mary's Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of subjects whose CIS score has improved under 76 at week 4 4 weeks No
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