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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.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02418130
Recruitment Status : Completed
First Posted : April 16, 2015
Last Update Posted : April 16, 2015
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.

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.

Condition or disease Intervention/treatment Phase
Fatigue Drug: Ursodeoxycholic acid, taurine, ginsenoside, thiamine, inositol Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 166 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : October 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Arm Intervention/treatment
Experimental: UDCA004
Drug: Ursodeoxycholic acid, taurine, ginsenoside, thiamine, inositol
Placebo Comparator: Placebo of UDCA004
Placebo of UDCA004
Drug: Placebo

Primary Outcome Measures :
  1. Rate of subjects whose CIS score has improved under 76 at week 4 [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02418130

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Korea, Republic of
Seoul St. Mary's Hospital
Seoul, Korea, Republic of, 137-701
Sponsors and Collaborators
Daewoong Pharmaceutical Co. LTD.

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Responsible Party: Daewoong Pharmaceutical Co. LTD. Identifier: NCT02418130     History of Changes
Other Study ID Numbers: DW_UDCA004
First Posted: April 16, 2015    Key Record Dates
Last Update Posted: April 16, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
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Signs and Symptoms
Ursodeoxycholic Acid
Vitamin B Complex
Growth Substances
Physiological Effects of Drugs
Cholagogues and Choleretics
Gastrointestinal Agents