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

Phase 4

• Conditions: Fatigue Symptom
• Interventions: Drug: DA-5515; Drug: Placebo of DA-5515

• Registration Number: NCT03542721
• Lead Sponsor: Dong-A Pharmaceutical

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2018-01-17
• Study First Submitted: 2018-05-18
• Study First Submitted QC: 2018-05-30
• Study First Posted: 2018-05-31
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-01
• Last Update Posted: 2018-06-04
• Primary Completion: 2019-06
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 204

Inclusion Criteria

• Rutherford's category 0/0 or Ⅰ/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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DA-5515 Capsule	DA-5515	Garlic oil, Gingko biloba ex.,Crataegus berry ex.,Melissa officinalis ex., (three times a day)
Placebo of DA-5515 Capsule	Placebo of DA-5515	Placebo of DA-5515 (three times a day)

Primary Outcome Measures

Name	Time	Method
CIS(Checklist Individual Strength) less than or equal to 76	8weeks	Rate of subjects whose CIS score has improved less than or equal to 76 at 8weeks

Trial Locations

Locations (1)

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