Effect of DA-5515 (Circulan® Soft Cap.) in Patients With... | NCT03542721

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

NCT03542721

Sponsor

Dong-A Pharmaceutical

Status

Unknown status

Last Update Posted

Jun 4, 2018Actual

Enrollment

204Estimated

Phase

Phase 4

Conditions

Fatigue Symptom

Interventions

DA-5515
Placebo of DA-5515

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 17, 2018Actual

Primary Completion Date

Jun 2019Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

May 18, 2018

First Submission Date that Met QC Criteria

May 30, 2018

First Posted Date

May 31, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 1, 2018

Last Update Posted Date

Jun 4, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

204Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo of DA-5515 Capsule	Placebo Comparator	Placebo of DA-5515 (three times a day)	Drug: Placebo of DA-5515
DA-5515 Capsule	Experimental	Garlic oil, Gingko biloba ex.,Crataegus berry ex.,Melissa officinalis ex., (three times a day)	Drug: DA-5515

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DA-5515	Drug	Crataegi ethanol extract, Garlic oil, Ginkgo leaf extract, Melissa folium extract (three times a day)	DA-5515 Capsule

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ran Seo	Contact	010-4547-1480		seoran@dreamwiz.com
WhanSeok Choi	Contact	02-2258-6285		fmchs@catholic.ac.kr

Overall Officials

Name	Affiliation	Role
WhanSeok Choi	Seoul St. Mary's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul St. Mary's Hospital	Recruiting	Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005221	Fatigue

Ancestor Terms

ID	Term
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided