Back to resultsEffect of DA-5515 (Circulan® Soft Cap.) in Patients With Chronic Fatigue Symptoms Due to Impaired Blood Circulation
Primary Purpose
Fatigue Symptom
Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DA-5515
Placebo of DA-5515
Sponsored by
About this trial
This is an interventional treatment trial for Fatigue Symptom focused on measuring chronic fatigue symptom, blood circulation
Eligibility Criteria
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
Sites / Locations
- Seoul St. Mary's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo of DA-5515 Capsule
DA-5515 Capsule
Arm Description
Placebo of DA-5515 (three times a day)
Garlic oil, Gingko biloba ex.,Crataegus berry ex.,Melissa officinalis ex., (three times a day)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03542721
Brief Title
Effect of DA-5515 (Circulan® Soft Cap.) in Patients With Chronic Fatigue Symptoms Due to Impaired Blood Circulation
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 17, 2018 (Actual)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dong-A Pharmaceutical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue Symptom
Keywords
chronic fatigue symptom, blood circulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
204 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo of DA-5515 Capsule
Arm Type
Placebo Comparator
Arm Description
Placebo of DA-5515 (three times a day)
Arm Title
DA-5515 Capsule
Arm Type
Experimental
Arm Description
Garlic oil, Gingko biloba ex.,Crataegus berry ex.,Melissa officinalis ex., (three times a day)
Intervention Type
Drug
Intervention Name(s)
DA-5515
Other Intervention Name(s)
Circulan® Soft Capule
Intervention Description
Crataegi ethanol extract, Garlic oil, Ginkgo leaf extract, Melissa folium extract (three times a day)
Intervention Type
Drug
Intervention Name(s)
Placebo of DA-5515
Other Intervention Name(s)
Placebo capsule
Intervention Description
Placebo (three times a day)
Primary Outcome Measure Information:
Title
CIS(Checklist Individual Strength) less than or equal to 76
Description
Rate of subjects whose CIS score has improved less than or equal to 76 at 8weeks
Time Frame
8weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ran Seo
Phone
010-4547-1480
Email
seoran@dreamwiz.com
First Name & Middle Initial & Last Name or Official Title & Degree
WhanSeok Choi
Phone
02-2258-6285
Email
fmchs@catholic.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
WhanSeok Choi
Organizational Affiliation
Seoul St. Mary's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ran Seo
Phone
010-4547-1480
Email
seoran@dreamwiz.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of DA-5515 (Circulan® Soft Cap.) in Patients With Chronic Fatigue Symptoms Due to Impaired Blood Circulation
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