Effect of DA-5515 (Circulan® Soft Cap.) in Patients With Chronic Fatigue Symptoms Due to Impaired Blood Circulation

Fatigue Symptom Clinical Trial

Official title:

A Placebo-controlled, Randomized, Double-blind, Parallel, Multi-center Clinical Trial to Evaluate the Efficacy and Safety of DA-5515 (Circulan® Soft Cap.) in Patients With Chronic Fatigue Symptoms Due to Impaired Blood Circulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03542721
• Other study ID #: DA-5515
• Status: Recruiting
• Phase: Phase 4
• Start date: January 17, 2018
• Est. completion date: December 2019

Study information

• Verified date: June 2018
• Source: Dong-A Pharmaceutical
• Contact: Ran Seo
• Phone: 010-4547-1480
• Email: seoran[@]dreamwiz.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the present clinical study is to evaluate the efficacy and safety of the DA-5515 (Circulan Soft Cap.) in patients with chronic fatigue symptoms due to impaired blood circulation.

Description:

This study is conducting to assess the efficacy and safety of the DA-5515 (Circulan Soft Cap.), which has been known to have a fatigue recovery effect due to impaired blood circulation.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 204
• Est. completion date: December 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 79 Years

Eligibility

Inclusion Criteria:

• Rutherford's category 0/0 or ?/1

• ABI <1.0

• CIS greater than 76

• HADS less than or equal to 10

• Subjects who have fatigue symptoms more than 1 month

Exclusion Criteria:

• Subjects who have diseases that can cause fatigue

• Subjects who are taking medication that can cause fatigue

Related Conditions & MeSH terms

• Fatigue
• Fatigue Symptom

Intervention

Drug:
• DA-5515
Crataegi ethanol extract, Garlic oil, Ginkgo leaf extract, Melissa folium extract (three times a day)
• Placebo of DA-5515
Placebo (three times a day)

Locations

Country	Name	City	State
Korea, Republic of	Seoul St. Mary's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Dong-A Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CIS(Checklist Individual Strength) less than or equal to 76	Rate of subjects whose CIS score has improved less than or equal to 76 at 8weeks	8weeks