Fatigue Clinical Trial
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 |
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.
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul St. Mary's Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Daewoong Pharmaceutical Co. LTD. |
Korea, Republic of,
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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