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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.

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ClinicalTrials.gov Identifier: NCT02418130
Recruitment Status : Completed
First Posted : April 16, 2015
Last Update Posted : April 16, 2015
Sponsor:
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
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 ]


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

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 ClinicalTrials.gov identifier (NCT number): NCT02418130


Locations
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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.
ClinicalTrials.gov 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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Inositol
Fatigue
Signs and Symptoms
Thiamine
Ursodeoxycholic Acid
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Cholagogues and Choleretics
Gastrointestinal Agents