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.

Phase 4

Completed

• Conditions: Fatigue
• Interventions: Drug: Ursodeoxycholic acid, taurine, ginsenoside, thiamine, inositol; Drug: Placebo

• Registration Number: NCT02418130
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-08
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-04
• Study First Submitted QC: 2015-04-15
• Last Update Submitted: 2015-04-15
• Study First Posted: 2015-04-16
• Last Update Posted: 2015-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 166

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UDCA004	Ursodeoxycholic acid, taurine, ginsenoside, thiamine, inositol	UDCA004
Placebo of UDCA004	Placebo	Placebo of UDCA004

Primary Outcome Measures

Name	Time	Method
Rate of subjects whose CIS score has improved under 76 at week 4	4 weeks

Trial Locations

Locations (1)

Seoul St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of