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.

Daewoong Pharmaceutical

Status and phase: Completed; Phase 4

Conditions: Fatigue

Treatments: Drug: Placebo; Drug: Ursodeoxycholic acid, taurine, ginsenoside, thiamine, inositol

Study type: Interventional

Funder types: Industry

Identifiers

NCT02418130

DW_UDCA004

Details and patient eligibility

About

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.

Enrollment: 166 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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166 participants in 2 patient groups, including a placebo group

UDCA004

Experimental group

Description:

UDCA004

Treatment:

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

Placebo of UDCA004

Placebo Comparator group

Description:

Placebo of UDCA004

Treatment:

Drug: Placebo